Data / Medical devices / United States / Fetzer Surgical, LLC
Fetzer Surgical, LLC: FDA-registered device maker in Scottsdale, AZ, United States, 7 510(k) clearances
Fetzer Surgical, LLC is registered with the FDA (registration 3010687973) in Scottsdale, AZ, United States. It lists 125 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 25, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010687973
- Address
- 9217 E. Verde Grove Vw., Scottsdale, AZ, United States, 85255
- Owner or operator
- Fetzer Surgical, LLC (10046280)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- February 27, 2014
- Registered through
- 2027
- Brand names listed
- Cannula, Subprapubic
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Ent | KCJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Applier, Surgical, Clip | GDO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Awl | HWJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Brace, Drill | HXY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bur, Surgical, General & Plastic Surgery | GFF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Caliper, Ophthalmic | HOE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cannula And Trocar, Suprapubic, Non-Disposable | FBM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cannula, Injection | FGY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cannula, Ophthalmic | HMX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel (Osteotome) | KDG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel, Middle-Ear | JYE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel, Nasal | KAN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel, Osteotome, Surgical | EMM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp | HXD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp, Non-Electrical | FFN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp, Uterine | HGC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Crimper, Wire, Ent, Non-Sterile | NNN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette, Adenoid | KBJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette, Nasal | KAP | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette, Surgical, Dental | EMK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette, Uterine | HCY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dermatome | GFD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dilator, Cervical, Fixed Size | HDQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dilator, Lachrymal | HNW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dilator, Tracheal | KCG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dilator, Vessel, Surgical | DWP | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Elevator, Ent | KAD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Excavator, Ear | JYH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, Biopsy, Gynecological | HFB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, Surgical, Gynecological | HCZ | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, Tooth Extractor, Surgical | EMG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, Tube Introduction | BWB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Fork, Tuning | GWX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hemostat | HRQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hook, Bone | KIK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hook, Microsurgical Ear | JYL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hook, Ophthalmic | HNQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hook, Tracheal | KCH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Microsurgical | GZX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Introducer, Sphere | HNP | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Irrigator, Sinus | KAR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Knife, Amputation | GDN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Knife, Ent | KTG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ligator, Hemorrhoidal | FHN | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mallet, Surgical, General & Plastic Surgery | GFJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Marker, Ocular | HMR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mirror, Ent | KAI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mobilizer, Ent | KAJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Percussor | GWZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Probe And Director, Gastro-Urology | FGM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Probe, Lachrymal | HNL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Probe, Periodontic | EIX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rasp, Nasal | KBA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor, Ent | KAL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor, Ophthalmic | HNI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor, Self-Retaining | FFO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor, Self-Retaining, For Neurosurgery | GZT | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor, Vaginal | HDL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ring, Ophthalmic (Flieringa) | HNH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rongeur, Manual | HAE | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Saw, Manual And Accessories | GDR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, Episiotomy | HDK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, Nasal | KBD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, Ophthalmic | HNF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scoop | FHL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Snare, Tonsil | KBZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spatula, Ophthalmic | HND | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Specula, Ophthalmic | HNC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Speculum, Rectal | FFQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Speculum, Vaginal, Metal | HDF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spud, Ophthalmic | HNA | 1 | Repackager or relabeler, Specification developer | 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, Specification developer | accessdata.fda.gov |
| Tamp | HXG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Trephine, Manual, Ophthalmic | HRH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Trocar, Ent | KTE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Twister, Wire | HXS | 1 | Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 25, 2021 | K213386 | Titan Manufacturing Bipolar Forceps | GEI | Substantially Equivalent | Titan Manufacturing, Inc. | 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 |
| May 8, 2018 | K172661 | Fetzer Medical Gynecological Forceps | HCZ | Substantially Equivalent | Fetzer Medical GmbH & Co. KG | accessdata.fda.gov |
| June 29, 2017 | K163524 | Vessel Dilator | DWP | Substantially Equivalent | Fetzer Medical GmbH & Co. KG | 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 |
Compare with other makers
- All makers of Osteotome
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Forceps, Biopsy, Gynecological
- All makers of Trocar, Ent
- All makers of Hook, Surgical, General & Plastic Surgery
- All makers of Scissors, Ophthalmic
Updated October 25, 2021. 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.