Data / Medical devices / United States / Accurate Surgical & Scientific Instruments Corp.
Accurate Surgical & Scientific Instruments Corp.: FDA-registered device maker in Westbury, NY, United States, 15 510(k) clearances
Accurate Surgical & Scientific Instruments Corp. is registered with the FDA (registration 2434839) in Westbury, NY, United States. It lists 105 device types. The FDA files 15 510(k) clearances under its listings, the newest dated March 12, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2434839
- Address
- 300 Shames DR., Westbury, NY, United States, 11590
- Owner or operator
- ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. (2434839)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- July 8, 1992
- Registered through
- 2026
- Brand names listed
- 100-101-330, 100-101-332, 100-102-100, 101000BP, 101001BP, 1010022BP, 101002BP, 101003BP and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Arthroscope | HRX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Brush, Scrub, Operating-Room | GEC | 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 |
| 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 |
| Curette | HTF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Ear | JYG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Ethmoid | KAO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Nasal | KAP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Ophthalmic | HNZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Depressor, Orbital | HNX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Device, Irrigation, Ocular Surgery | KYG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Electrode, Electrosurgical | JOS | 2 | 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, General & Plastic Surgery | GEG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Biopsy, Gynecological | HFB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Wire Holding | HYA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gauge, Lens, Ophthalmic | HLN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gouge, Surgical, General & Plastic Surgery | GDH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Headlight, Fiberoptic Focusing | FCT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Hemostat | HRQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Gastro-Urology | FHB | 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 |
| Instrument, Compression | HWN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 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 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Microsurgical | GZX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Ear | JYO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Nasal | KAS | 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 |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lens, Guide, Intraocular | KYB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Light Source, Fiberoptic, Routine | FCW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mallet, Surgical, General & Plastic Surgery | GFJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Marker, Ocular | HMR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mirror, Ent | KAI | 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 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Suturing, Reusable | GDL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Orchidometer | OLH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pliers, Surgical | HTC | 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 |
| Retainer, Surgical | GCZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Ent | KAL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Non-Self-Retaining | FGN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Ophthalmic | HNI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Self-Retaining | FFO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rongeur | HTX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rongeur, Nasal | KBB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Saw, Nasal | KBC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Ear | JZB | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Nasal | KBD | 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 |
| Sound, Urethral, Metal Or Plastic | FBX | 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, Ophthalmic | HNC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Ent | EPY | 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 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Table, Surgical With Orthopedic Accessories, Manual | JEB | 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 |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Trephine | HWK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Trocar, Ent | KTE | 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 |
|---|
| March 12, 2015 | K143662 | Bissinger Monopolar Forceps and Cables | GEI | Substantially Equivalent | Medagent, Inc. | accessdata.fda.gov |
| January 18, 2008 | K072124 | BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODES | GEI | Substantially Equivalent | Black & Black Surgical, Inc. | accessdata.fda.gov |
| July 29, 2005 | K051429 | CLARIS NON-STICK BIPOLAR FORCEPS | GEI | Substantially Equivalent | Guenter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| October 27, 2004 | K042077 | BITECH BIPOLAR SCISSORS | GEI | Substantially Equivalent | Guenter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| October 22, 2004 | K040223 | POLYVAC INSTRUMENT DELIVERY SYSTEM | KCT | Substantially Equivalent | Symmetry Medical USA, Inc. | accessdata.fda.gov |
| July 10, 2001 | K011997 | MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX | GCJ | Substantially Equivalent | Pajunk GmbH | accessdata.fda.gov |
| August 6, 1998 | K981919 | BISSINGER CABLES, CAT. NO. 801000XX | GEI | Substantially Equivalent | Guenter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| September 19, 1997 | K972901 | AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD | GEI | Substantially Equivalent | American Biosurgical, Inc. | accessdata.fda.gov |
| October 18, 1995 | K953889 | AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD | GEI | Substantially Equivalent | American Biosurgical, Inc. | accessdata.fda.gov |
| September 1, 1995 | K953484 | POLLUX OA/POLLUX 30A/POLLUX 70A | HRX | Substantially Equivalent | Pollux Endoscopy, Inc. | accessdata.fda.gov |
| May 25, 1995 | K943662 | LAPARASCOPE | HET | Substantially Equivalent | Pollux Endoscopy, Inc. | accessdata.fda.gov |
| September 15, 1989 | K895331 | ELECTROSURGICAL ELECTRODE | JOS | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
| June 26, 1987 | K872271 | VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS | GEN | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
| November 5, 1981 | K812702 | TECHNICATOR | GEI | Substantially Equivalent | Cameron-Miller, Inc. | accessdata.fda.gov |
| July 28, 1981 | K811820 | BIPOLAR COAGULATING FORCEPS | GEI | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
Compare with other makers
Updated March 12, 2015. 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.