Cleared Traditional

APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS

K062169 · Applied Medical Resources Corp. · Obstetrics & Gynecology
Aug 2006
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K062169 is an FDA 510(k) clearance for the APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on August 24, 2006, 24 days after receiving the submission on July 31, 2006. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K062169 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2006
Decision Date August 24, 2006
Days to Decision 24 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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