Cleared Traditional

SYSTEM 3000 ELECTRONIC INSUFFLATOR (K913873) - FDA 510(k) Clearance

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

K913873 · Cabot Medical Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
204d
Days
Class 2
Risk

K913873 is an FDA 510(k) clearance for the SYSTEM 3000 ELECTRONIC INSUFFLATOR. 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 20, 1992 after a review of 204 days - an extended review cycle.

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 Cabot Medical Corp. devices

Submission Details

510(k) Number K913873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1991
Decision Date March 20, 1992
Days to Decision 204 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
44d slower than avg
Panel avg: 160d · This submission: 204d
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 K913873.
KARL STORZ ELECTRONIC LAPAROFLATOR
K934043 · KARL STORZ Endoscopy-America, Inc. · May 1994
KARL STORZ ELECTRONIC LAPAROFLATOR
K934114 · KARL STORZ Endoscopy-America, Inc. · May 1994
ELECTRONIC INSUFFLATOR MODEL 2054.61
K921756 · Richard Wolf Medical Instruments Corp. · Mar 1994
ELECTRONIC INSUFFLATOR, MODEL NO. 2054.60
K882185 · Richard Wolf Medical Instruments Corp. · Jun 1988
CARBON DIOXIDE INSUFFLATOR/LAPARO & HI FLOW LASER/
K871928 · Medline Industries, Inc. · Nov 1987
MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA
K845021 · Medline Industries, Inc. · May 1985