Boss Instruments, Ltd.
Gordonsville, VA, US
BOSS INSTRUMENTS, LTD. appears in FDA device records in Gordonsville, VA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Boss Instruments, Ltd. in 1998.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1056350 | 1000140363 | BOSS INSTRUMENTS, LTD. | 104 Sommerfield Drive, Gordonsville, VA 22942 US | 2026 | and 150 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GDOApplier, Surgical, Clip
- FAXBougie, Urological
- GEACannula, Surgical, General & Plastic Surgery
- GEJCarrier, Ligature
- EMLChisel, Bone, Surgical
- EMMChisel, Osteotome, Surgical
- FZOChisel, Surgical, Manual
- FFNClamp, Non-Electrical
- GDJClamp, Surgical, General & Plastic Surgery
- DXCClamp, Vascular
- EKTCurette, Endodontic
- EMKCurette, Surgical, Dental
- FZSCurette, Surgical, General Use
- DWPDilator, Vessel, Surgical
- GDIDissector, Surgical, General & Plastic Surgery
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- EMJElevator, Surgical, Dental
- GEGElevator, Surgical, General & Plastic Surgery
- EMIFile, Bone, Surgical
- GENForceps, General & Plastic Surgery
- EMHForceps, Rongeur, Surgical
- EMGForceps, Tooth Extractor, Surgical
- BWBForceps, Tube Introduction
- GDHGouge, Surgical, General & Plastic Surgery
- FZXGuide, Surgical, Instrument
- GDZHandle, Scalpel
- EMDHemostat, Surgical
- FHQHolder, Needle, Gastroenterologic
- GDGHook, Surgical, General & Plastic Surgery
- HCFInstrument, Ligature Passing And Knot Tying
- GZXInstrument, Microsurgical
- HAOInstrument, Surgical, Non-Powered
- DZNInstruments, Dental Hand
- DWSInstruments, Surgical, Cardiovascular
- GDNKnife, Amputation
- EMFKnife, Surgical
- GCJLaparoscope, General & Plastic Surgery
- GFJMallet, Surgical, General & Plastic Surgery
- EAXMirror, Mouth
- GDMNeedle, Aspiration And Injection, Reusable
- GDLNeedle, Suturing, Reusable
- GFIOsteotome, Manual
- GXJPunch, Skull
- GACRasp, Surgical, General & Plastic Surgery
- GADRetractor
- EIGRetractor, All Types
- FDGRetractor, Fiberoptic
- FFORetractor, Self-Retaining
- GZTRetractor, Self-Retaining, For Neurosurgery
- HAERongeur, Manual
- GDRSaw, Manual And Accessories
- EQHSource, Carrier, Fiberoptic Light
- GAFSpatula, Surgical, General & Plastic Surgery
- FXGSpecula Accessories
- EPYSpeculum, Ent
- FXESpeculum, Non-Illuminated
- FFQSpeculum, Rectal
- FTYTape, Measuring, Rulers And Calipers
- EYRTourniquet, Gastro-Urology
- FSMTray, Surgical, Instrument
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2767-2020 | 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 procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris. | The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain