Cleared Special

K121336 - MODIFIED SURGIQUEST AIRSEAL OPTICAL TRO...

K121336 is an FDA 510(k) clearance for MODIFIED SURGIQUEST AIRSEAL OPTICAL TRO..., manufactured by Surgiquest, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Special 510(k) pathway after a 61-day FDA review.

K121336 · Surgiquest, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jul 2012
Decision
61d
Days
Class 2
Risk

K121336 is an FDA 510(k) clearance for the MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED I.... Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Surgiquest, Inc. (Milford, US). The FDA issued a Cleared decision on July 3, 2012 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Surgiquest, Inc. devices

FDA 510(k) Submission Details - K121336

510(k) Number K121336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2012
Decision Date July 03, 2012
Days to Decision 61 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 160d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

HIF Device Classification - Class 2, Special Controls

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIF Insufflator, Laparoscopic

All 93
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K121336.
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