DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE— 510(k) K901428
Substantially EquivalentTelemed Systems, Inc.
FDA 510(k) clearance K901428 for DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE, Substantially Equivalent on 1990-06-18. Applicant: Telemed Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Telemed Systems, Inc.
- Product code
- Code FDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hudson, MA, US
Recent devices under product code FDI
view allMore clearances from Telemed Systems, Inc.
view all- K020379 — PPD BALLOON DILATATION CATHETER
- 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
Adverse events under product code FDI
product code FDI- Death
- 6
- Injury
- 217
- Malfunction
- 1,544
- Total
- 1,767
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.