Cleared Traditional

K760717 - FLEXIBLE BIOPSY FORCEPS (FDA 510(k) Clearance)

Oct 1976
Decision
26d
Days
Class 1
Risk

K760717 is an FDA 510(k) clearance for the FLEXIBLE BIOPSY FORCEPS. This device is classified as a Surgical Instruments, G-u, Manual (and Accessories) (Class I - General Controls, product code KOA).

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on October 21, 1976, 26 days after receiving the submission on September 25, 1976.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4730.

Submission Details

510(k) Number K760717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1976
Decision Date October 21, 1976
Days to Decision 26 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary

Device Classification

Product Code KOA — Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class I - General Controls
CFR Regulation 21 CFR 876.4730