Cleared Traditional

K211104 - AirSeal dV Solution- AirSeal Cannula Ca...

K211104 is the FDA 510(k) clearance for AirSeal dV Solution- AirSeal Cannula Ca... by Conmed Corporation. It is a Class 2 Obstetrics & Gynecology device (product code HIF) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K211104 · Conmed Corporation · Obstetrics & Gynecology device
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Aug 2021
Decision
128d
Days
Class 2
Risk

K211104 is an FDA 510(k) clearance for the AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered T.... Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on August 19, 2021 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K211104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2021
Decision Date August 19, 2021
Days to Decision 128 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 160d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 80
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K211104.
Gas Insufflator
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K212786 · Core Access Surgical Technologies, Inc. · Feb 2022
EVA15
K202799 · Palliare , Ltd. · Oct 2020
PNEUMOCLEAR
K201361 · W.O.M. World of Medicine GmbH · Jul 2020
EVA 15 Insufflator
K193520 · Palliare , Ltd. · Jul 2020