Cleared Traditional

REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS

K022748 · Medical Device Services · Obstetrics & Gynecology
Oct 2002
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K022748 is an FDA 510(k) clearance for the REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Medical Device Services (St. George, US). The FDA issued a Cleared decision on October 9, 2002, 51 days after receiving the submission on August 19, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K022748 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2002
Decision Date October 09, 2002
Days to Decision 51 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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