FLEXIBLE ENDOSCOPIC SCISSORS— 510(k) K010412
Substantially EquivalentTelemed Systems, Inc.
FDA 510(k) clearance K010412 for FLEXIBLE ENDOSCOPIC SCISSORS, Substantially Equivalent on 2001-04-02. 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
- Hudson, MA, US
Recent devices under product code OCZ
view allMore clearances from Telemed Systems, Inc.
view all- K020379 — PPD BALLOON DILATATION CATHETER
- K013737 — MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
- 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
- K974312 — REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR
Data sourced from openFDA. This site is unofficial and independent of the FDA.