Cleared Traditional

SEDLACEK HANDLE

K926179 · Simpson/Basye, Inc. · Obstetrics & Gynecology
Mar 1994
Decision
472d
Days
Class 2
Risk

About This 510(k) Submission

K926179 is an FDA 510(k) clearance for the SEDLACEK HANDLE, a Electrocautery, Gynecologic (and Accessories) (Class II — Special Controls, product code HGI), submitted by Simpson/Basye, Inc. (West Chester, US). The FDA issued a Cleared decision on March 25, 1994, 472 days after receiving the submission on December 8, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4120.

Submission Details

510(k) Number K926179 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1992
Decision Date March 25, 1994
Days to Decision 472 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HGI — Electrocautery, Gynecologic (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4120

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