Cleared Traditional

TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES

K942389 · Hogan & Hartson · Obstetrics & Gynecology
Feb 1996
Decision
639d
Days
Class 2
Risk

About This 510(k) Submission

K942389 is an FDA 510(k) clearance for the TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on February 16, 1996, 639 days after receiving the submission on May 18, 1994. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K942389 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 1994
Decision Date February 16, 1996
Days to Decision 639 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

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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