Cleared Traditional

DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE

K941334 · Davol, Inc. · Obstetrics & Gynecology
Jun 1994
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K941334 is an FDA 510(k) clearance for the DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on June 14, 1994, 88 days after receiving the submission on March 18, 1994. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K941334 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1994
Decision Date June 14, 1994
Days to Decision 88 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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