Cleared Traditional

K911179 - VERRES NEEDLES 5 & 6 INCHES

K911179 is an FDA 510(k) clearance for VERRES NEEDLES 5 & 6 INCHES, manufactured by Northgate Technologies, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K911179 · Northgate Technologies, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
240d
Days
Class 2
Risk

K911179 is an FDA 510(k) clearance for the VERRES NEEDLES 5 & 6 INCHES. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Northgate Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on November 13, 1991 after a review of 240 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.

FDA 510(k) Submission Details - K911179

510(k) Number K911179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1991
Decision Date November 13, 1991
Days to Decision 240 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
79d slower than avg
Panel avg: 161d · This submission: 240d
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 K911179.
GENERAL USE KIT #7-510-20
K914403 · Northgate Technologies, Inc. · Nov 1991
CIRCON ACMI CAT.# LAP 9900
K914101 · Circon Video · Nov 1991
PRESSURE GUARD
K913772 · Beacon Laboratories, Inc. · Nov 1991
SNOWDEN-PENCER INSUFFLATOR TUBING SET
K913835 · Snowden-Pencer · Nov 1991
MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR
K912044 · Multigon Industries, Inc. · Jun 1991
LAPAROSCOPIC INSUFLATION Y TUBING
K911479 · United States Endoscopy Group, Inc. · Apr 1991
K911179 · VERRES NEEDLES 5 & 6 INCHES
Download PDF Northgate Technologie…