TELEMED SYSTEMS RETRIEVAL BASKET— 510(k) K974300
Substantially EquivalentTelemed Systems, Inc.
FDA 510(k) clearance K974300 for TELEMED SYSTEMS RETRIEVAL BASKET, Substantially Equivalent on 1997-12-19. Applicant: Telemed Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Telemed Systems, Inc.
- Product code
- Code OCZ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
Recent devices under product code OCZ
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- K013737 — MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
- K010412 — FLEXIBLE ENDOSCOPIC SCISSORS
- K992390 — HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD
- K992402 — 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH
Recalls naming K974300
K-number listed on FDA's recall record- Z-2229-2021 — 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
- Z-2230-2021 — 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K974300.
Data sourced from openFDA. This site is unofficial and independent of the FDA.