Cleared Traditional

GRASPING FORCEPS

K896058 · Annex Medical, Inc. · Gastroenterology & Urology
Dec 1989
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K896058 is an FDA 510(k) clearance for the GRASPING FORCEPS, a Surgical Instruments, G-u, Manual (and Accessories) (Class I — General Controls, product code KOA), submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 28, 1989, 71 days after receiving the submission on October 18, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4730.

Submission Details

510(k) Number K896058 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 1989
Decision Date December 28, 1989
Days to Decision 71 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