Cleared Traditional

NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE

K926021 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology
Apr 1994
Decision
493d
Days
Class 2
Risk

About This 510(k) Submission

K926021 is an FDA 510(k) clearance for the NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on April 7, 1994, 493 days after receiving the submission on November 30, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K926021 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 1992
Decision Date April 07, 1994
Days to Decision 493 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HET — Laparoscope, Gynecologic (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1720

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