Cleared Traditional

K913835 - SNOWDEN-PENCER INSUFFLATOR TUBING SET

K913835 is the FDA 510(k) clearance for SNOWDEN-PENCER INSUFFLATOR TUBING SET by Snowden-Pencer. It is a Class 2 Obstetrics & Gynecology device (product code HIF) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K913835 · Snowden-Pencer · Obstetrics & Gynecology device
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Nov 1991
Decision
73d
Days
Class 2
Risk

K913835 is an FDA 510(k) clearance for the SNOWDEN-PENCER INSUFFLATOR TUBING SET. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Snowden-Pencer (Tucker, US). The FDA issued a Cleared decision on November 7, 1991 after a review of 73 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.

View all Snowden-Pencer devices

Submission Details

510(k) Number K913835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1991
Decision Date November 07, 1991
Days to Decision 73 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
87d faster than avg
Panel avg: 160d · This submission: 73d
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 82
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K913835.
RECIRCULATION KIT #7-510-18
K914402 · Northgate Technologies, Inc. · Nov 1991
GENERAL USE KIT #7-510-20
K914403 · Northgate Technologies, Inc. · Nov 1991
VERRES NEEDLES 5 & 6 INCHES
K911179 · Northgate Technologies, Inc. · Nov 1991
LAPAROSCOPIC INSUFLATION Y TUBING
K911479 · United States Endoscopy Group, Inc. · Apr 1991
NORTHGATE TECHNOLOGIES MODEL 7201 INSUFFLATOR
K905481 · Northgate Technologies, Inc. · Mar 1991
THE DART
K905549 · Dexide, Inc. · Feb 1991