Cleared Traditional

K943954 - ASPEN SURGICAL SYSTEMS INSUFFLATION TUB...

K943954 is an FDA 510(k) clearance for ASPEN SURGICAL SYSTEMS INSUFFLATION TUB..., manufactured by Conmedcorp. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K943954 · Conmedcorp · Obstetrics & Gynecology device
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Nov 1994
Decision
92d
Days
Class 2
Risk

K943954 is an FDA 510(k) clearance for the ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Conmedcorp (Dayton, US). The FDA issued a Cleared decision on November 15, 1994 after a review of 92 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.

View all Conmedcorp devices

FDA 510(k) Submission Details - K943954

510(k) Number K943954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1994
Decision Date November 15, 1994
Days to Decision 92 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 160d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 92
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K943954.
MODEL 2231 CO2 INSUFFLATOR
K934884 · Richard Wolf Medical Instruments Corp. · Feb 1995
DEXIDE INSUFFLATION TUBING WITH FILTER
K944509 · Dexide, Inc. · Feb 1995
DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER
K945789 · Deroyal Industries, Inc. · Feb 1995
NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600
K935862 · Northgate Technologies, Inc. · Aug 1994
KARL STORZ ELECTRONIC LAPAROFLATOR
K934043 · KARL STORZ Endoscopy-America, Inc. · May 1994
KARL STORZ ELECTRONIC LAPAROFLATOR
K934114 · KARL STORZ Endoscopy-America, Inc. · May 1994