510(k) K974300 ยท OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
TELEMED SYSTEMS RETRIEVAL BASKET
| Applicant | Telemed Systems, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Dec 19, 1997 |
| Received | Nov 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974300
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2021 | Shent USA, Inc. Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208
Intended use: single use accessory devices used through the working channel of a GI endoscope Completed |
OCZ | None listed |
| Jan 12, 2021 | Shent USA, Inc. Grasper/Retriever, Alligator Jaw, Rat Tooth
2.4 mm x 8 mm x 230 cm
Catalog Number: 7226
Intended use: single use accessory devices used through the working channel of a GI endoscope Completed |
OCZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.