Data / Medical devices / United States / Boss Instruments, Ltd.
Boss Instruments, Ltd.: FDA-registered device maker in Gordonsville, VA, United States, 14 510(k) clearances
Boss Instruments, Ltd. is registered with the FDA (registration 1056350) in Gordonsville, VA, United States. It lists 160 device types. The FDA files 14 510(k) clearances under its listings, the newest dated September 15, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1056350
- FEI number
- 1000140363
- Address
- 104 Sommerfield Drive, Gordonsville, VA, United States, 22942
- Owner or operator
- BOSS INSTRUMENTS, LTD. (9005081)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- March 19, 1993
- Registered through
- 2026
- Brand names listed
- Amputation Knife, BOS, BOSS, Bone Hook, Boss Dental Retractors, Boss Fiber Optic Cable, Boss Mirror, Boss Obstetrical Forceps and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Applier, Surgical, Clip | GDO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Awl | HWJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bougie, Urological | FAX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Caliper, Ophthalmic | HOE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Ear | JYC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Ophthalmic | HMX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Carrier, Ligature | GEJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Chisel (Osteotome) | KDG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Middle-Ear | JYE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Nasal | KAN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Osteotome, Surgical | EMM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp | HXD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Non-Electrical | FFN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Uterine | HGC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Countersink | HWW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Crimper, Wire, Ent, Non-Sterile | NNN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Crimper, Wire, Ent, Sterile | JXT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette | HTF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Ear | JYG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Endodontic | EKT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Ophthalmic | HNZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Surgical, Dental | EMK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Uterine | HCY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cystotome | HNY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Depressor, Orbital | HNX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dilator, Cervical, Fixed Size | HDQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dilator, Lachrymal | HNW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dilator, Tracheal | KCG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dilator, Vessel, Surgical | DWP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Elevator, Ent | KAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Excavator, Ear | JYH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Extractor | HWB | 1 | Repackager or relabeler | accessdata.fda.gov |
| File, Bone, Surgical | EMI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Biopsy, Gynecological | HFB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Obstetrical | HDA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Rongeur, Surgical | EMH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Surgical, Gynecological | HCZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Tooth Extractor, Surgical | EMG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Tube Introduction | BWB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Fork | HXE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gouge, Surgical, General & Plastic Surgery | GDH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hemostat | HRQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hemostat, Surgical | EMD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Bone | KIK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Microsurgical Ear | JYL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Ophthalmic | HNQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Tracheal | KCH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Impactor | HWA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Cast Application/Removal, Manual | LGG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Microsurgical | GZX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Irrigator, Sinus | KAR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Amputation | GDN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Ear | JYO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Ent | KTG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Loop, Wire | JYQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mallet, Surgical, General & Plastic Surgery | GFJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mirror, Ent | KAI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mobilizer, Ent | KAJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Aspiration And Injection, Reusable | GDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Ophthalmic Suturing | HNM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Suturing, Reusable | GDL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Osteotome | HWM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Passer | HWQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pick, Microsurgical Ear | JYT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Probe | HXB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Probe, Ent | KAK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Probe, Lachrymal | HNL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Probe, Trabeculotomy | HNK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Antrum | KAW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Corneo-Scleral | HNJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Ent | KTF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Skull | GXJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rasp, Ear | JYY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rasp, Nasal | KBA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Ent | KAL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Fiberoptic | FDG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Retractor, Ophthalmic | HNI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Self-Retaining | FFO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Self-Retaining, For Neurosurgery | GZT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Vaginal | HDL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Ring, Ophthalmic (Flieringa) | HNH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rod, Measuring Ear | JYZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rongeur | HTX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rongeur, Manual | HAE | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Saw | HSO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Saw, Manual And Accessories | GDR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Ophthalmic | HNF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Orthopedic, Surgical | HRR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Snare, Ear | JZD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Snare, Nasal | KBE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Snare, Tonsil | KBZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sound, Uterine | HHM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Source, Carrier, Fiberoptic Light | EQH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spatula, Ophthalmic | HND | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Specula Accessories | FXG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Specula, Ophthalmic | HNC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Non-Illuminated | FXE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Rectal | FFQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Vaginal, Metal | HDF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spud, Ophthalmic | HNA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stripper, Surgical | HRT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tamp | HXG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tourniquet, Gastro-Urology | EYR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Trephine | HWK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Trephine, Manual, Ophthalmic | HRH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Trocar, Ent | KTE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Ear Suction | JZF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Tonsil Suction | KCB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Twister, Wire | HXS | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| September 15, 2026 | K260446 | Tontarra Punches and Rongeurs | HAE | Substantially Equivalent | Tontarra Medizintechnik GmbH | accessdata.fda.gov |
| June 13, 2018 | K173259 | Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories | KCT | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| September 9, 2016 | K161004 | Self-retaining Retractor | GZT | Substantially Equivalent | Fetzer Medical GmbH & Co. KG | accessdata.fda.gov |
| February 29, 2016 | K150468 | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | HAE | Substantially Equivalent | K2 Medical GmbH & Co. KG | accessdata.fda.gov |
| April 30, 2012 | K120492 | K2 MEDICAL VASCULAR CLAMPS | DXC | Substantially Equivalent | K2 Medical GmbH & Co. KG | accessdata.fda.gov |
| August 31, 2010 | K100518 | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | DWP | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| April 29, 2010 | K100517 | INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX | HDA | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| December 3, 2009 | K092840 | INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL | HCZ | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| October 26, 2009 | K092544 | INSTRUMED VASCULAR CLAMPS | DXC | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| August 8, 2008 | K081651 | INSTRUMED RONGEUR | HAE | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| August 2, 2007 | K071771 | INSTRUMED RETRACTORS | GZT | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| April 16, 2004 | K040855 | INSTRUMED LAPAROSCOPE AND ACCESSORIES | GEI | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| June 18, 1998 | K980002 | KOALA VASCULAR CLAMPS AND INSERTS | DXC | Substantially Equivalent | Boss Instruments, Ltd. | accessdata.fda.gov |
| March 7, 1997 | K962545 | DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE | KCT | Substantially Equivalent | Sterilization Cassette Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|
| June 26, 2020 | 86040 | Class II | Terminated | BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy proc | The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure. | accessdata.fda.gov |
Compare with other makers
Updated September 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.