Cleared Traditional

DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP

K921405 · Davol, Inc. · Obstetrics & Gynecology
Mar 1994
Decision
731d
Days
Class 2
Risk

About This 510(k) Submission

K921405 is an FDA 510(k) clearance for the DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP, a Coagulator, Laparoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code HFG), submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on March 25, 1994, 731 days after receiving the submission on March 24, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.

Submission Details

510(k) Number K921405 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1992
Decision Date March 25, 1994
Days to Decision 731 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HFG — Coagulator, Laparoscopic, Unipolar (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4160

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