REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR— 510(k) K974312

Substantially Equivalent

Telemed Systems, Inc.

FDA 510(k) clearance K974312 for REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR, Substantially Equivalent on 1998-01-21. Applicant: Telemed Systems, Inc..

Clearance details

Applicant: Telemed Systems, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 1997-11-17
Decision date: 1998-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

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Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.