Cleared Traditional

3000 ELECTRONIC INSUFFLATOR MODIFICATION (K934115) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934115 · Cabot Medical Corp. · Obstetrics & Gynecology device
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Mar 1995
Decision
568d
Days
Class 2
Risk

K934115 is an FDA 510(k) clearance for the 3000 ELECTRONIC INSUFFLATOR MODIFICATION. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Cabot Medical Corp. (Langhorne, US). The FDA issued a Cleared decision on March 15, 1995 after a review of 568 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Cabot Medical Corp. devices

Submission Details

510(k) Number K934115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1993
Decision Date March 15, 1995
Days to Decision 568 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
408d slower than avg
Panel avg: 160d · This submission: 568d
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 46
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K934115.
OLYMPUS HIGH FLOW INSUFFLATION UNIT
K953162 · Olympus America, Inc. · Dec 1995
ELECTRONIC LAPAROFLATOR
K951694 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR
K951961 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
MODEL 2231 CO2 INSUFFLATOR
K934884 · Richard Wolf Medical Instruments Corp. · Feb 1995
KARL STORZ ELECTRONIC LAPAROFLATOR
K934043 · KARL STORZ Endoscopy-America, Inc. · May 1994
KARL STORZ ELECTRONIC LAPAROFLATOR
K934114 · KARL STORZ Endoscopy-America, Inc. · May 1994