Cleared Traditional

K911479 - LAPAROSCOPIC INSUFLATION Y TUBING

K911479 is an FDA 510(k) clearance for LAPAROSCOPIC INSUFLATION Y TUBING, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K911479 · United States Endoscopy Group, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
25d
Days
Class 2
Risk

K911479 is an FDA 510(k) clearance for the LAPAROSCOPIC INSUFLATION Y TUBING. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 25 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K911479

510(k) Number K911479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1991
Decision Date April 29, 1991
Days to Decision 25 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d faster than avg
Panel avg: 161d · This submission: 25d
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 178
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K911479.
VERRES NEEDLES 5 & 6 INCHES
K911179 · Northgate Technologies, Inc. · Nov 1991
SNOWDEN-PENCER INSUFFLATOR TUBING SET
K913835 · Snowden-Pencer · Nov 1991
MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR
K912044 · Multigon Industries, Inc. · Jun 1991
NORTHGATE TECHNOLOGIES MODEL 7201 INSUFFLATOR
K905481 · Northgate Technologies, Inc. · Mar 1991
LAPAROFLATOR ELECTRONIC 3509
K910883 · F.M. Wiest USA, Inc. · Mar 1991
LAP 3501 HIGH FLOW INSUFFLATOR
K905705 · Circon Acmi · Feb 1991
K911479 · LAPAROSCOPIC INSUFLATION Y TUBING
Download PDF United States Endosco…