Cleared Traditional

AMR MINI-LAPAROSCOPE

K962777 · Applied Medical Resources · Obstetrics & Gynecology
Aug 1997
Decision
385d
Days
Class 2
Risk

About This 510(k) Submission

K962777 is an FDA 510(k) clearance for the AMR MINI-LAPAROSCOPE, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on August 6, 1997, 385 days after receiving the submission on July 17, 1996. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K962777 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1996
Decision Date August 06, 1997
Days to Decision 385 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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