Cleared Traditional

SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE

K925957 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology
Jun 1994
Decision
560d
Days
Class 2
Risk

About This 510(k) Submission

K925957 is an FDA 510(k) clearance for the SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE, a Coagulator, Culdoscopic (and Accessories) (Class II — Special Controls, product code HFI), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on June 7, 1994, 560 days after receiving the submission on November 24, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.

Submission Details

510(k) Number K925957 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1992
Decision Date June 07, 1994
Days to Decision 560 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HFI — Coagulator, Culdoscopic (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4160

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