Cleared Traditional

LAPAROSTAT(TM)

K913300 · Cook Ob/Gyn · General & Plastic Surgery
Apr 1992
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K913300 is an FDA 510(k) clearance for the LAPAROSTAT(TM), a Apparatus, Electrosurgical (Class II — Special Controls, product code HAM), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on April 2, 1992, 252 days after receiving the submission on July 25, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K913300 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 1991
Decision Date April 02, 1992
Days to Decision 252 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code HAM — Apparatus, Electrosurgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4400

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