Cleared Traditional

DOMAIN SURGICAL SYSTEM

K121881 · Domain Surgical, Inc. · Obstetrics & Gynecology
Oct 2012
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K121881 is an FDA 510(k) clearance for the DOMAIN SURGICAL SYSTEM, a Electrocautery, Gynecologic (and Accessories) (Class II — Special Controls, product code HGI), submitted by Domain Surgical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 18, 2012, 114 days after receiving the submission on June 26, 2012. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4120.

Submission Details

510(k) Number K121881 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2012
Decision Date October 18, 2012
Days to Decision 114 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

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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