Cleared Traditional

K003792 - STRYKER HEATED INSUFFLATOR TUBE SET

K003792 is the FDA 510(k) clearance for STRYKER HEATED INSUFFLATOR TUBE SET by Stryker Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HIF) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K003792 · Stryker Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
75d
Days
Class 2
Risk

K003792 is an FDA 510(k) clearance for the STRYKER HEATED INSUFFLATOR TUBE SET. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Stryker Corp. (Santa Clara, US). The FDA issued a Cleared decision on February 21, 2001 after a review of 75 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 Stryker Corp. devices

Submission Details

510(k) Number K003792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2000
Decision Date February 21, 2001
Days to Decision 75 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 160d · This submission: 75d
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 81
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K003792.
HUMI-FLOW, MODEL 6-850-00/ 01/02
K010053 · Northgate Technologies, Inc. · Oct 2001
SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR
K002328 · Richard Wolf Medical Instruments Corp. · Aug 2001
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
K000180 · Richard Wolf Medical Instruments Corp. · Mar 2001
LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT
K991906 · Richard Wolf Medical Instruments Corp. · Nov 1999
CO2 GAS WARMER II, MODEL 6-800-00
K992381 · Northgate Technologies, Inc. · Sep 1999
OMNIFLATOR 7640 MODEL 7-640-00
K983326 · Northgate Technologies, Inc. · Feb 1999