Cleared Traditional

GOMCO CIRCUMCISION CLAMP

K894201 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology
Aug 1989
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K894201 is an FDA 510(k) clearance for the GOMCO CIRCUMCISION CLAMP, a Clamp, Circumcision (Class II — Special Controls, product code HFX), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on August 11, 1989, 56 days after receiving the submission on June 16, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K894201 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 1989
Decision Date August 11, 1989
Days to Decision 56 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HFX — Clamp, Circumcision
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530