Cleared Traditional

SHARPE ENDOSPONGE ASPIIRATOR

K921015 · Paladin Medical, Inc. · Obstetrics & Gynecology
May 1993
Decision
444d
Days
Class 2
Risk

About This 510(k) Submission

K921015 is an FDA 510(k) clearance for the SHARPE ENDOSPONGE ASPIIRATOR, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Paladin Medical, Inc. (Stillwater, US). The FDA issued a Cleared decision on May 21, 1993, 444 days after receiving the submission on March 3, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K921015 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1992
Decision Date May 21, 1993
Days to Decision 444 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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