Cleared Traditional

LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE

K930756 · Endo Technic Corp. · Obstetrics & Gynecology
Mar 1994
Decision
390d
Days
Class 2
Risk

About This 510(k) Submission

K930756 is an FDA 510(k) clearance for the LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Endo Technic Corp. (Atlanta, US). The FDA issued a Cleared decision on March 9, 1994, 390 days after receiving the submission on February 12, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K930756 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1993
Decision Date March 09, 1994
Days to Decision 390 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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