Cleared Traditional

K950219 - ENDOLAP INSUFFLATOR TUBING SET

K950219 is an FDA 510(k) clearance for ENDOLAP INSUFFLATOR TUBING SET, manufactured by Endolap, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K950219 · Endolap, Inc. · Obstetrics & Gynecology device
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Mar 1995
Decision
63d
Days
Class 2
Risk

K950219 is an FDA 510(k) clearance for the ENDOLAP INSUFFLATOR TUBING SET. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Endolap, Inc. (Orlando, US). The FDA issued a Cleared decision on March 23, 1995 after a review of 63 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 Endolap, Inc. devices

FDA 510(k) Submission Details - K950219

510(k) Number K950219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1995
Decision Date March 23, 1995
Days to Decision 63 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
97d faster than avg
Panel avg: 160d · This submission: 63d
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 83
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K950219.
OLYMPUS HIGH FLOW INSUFFLATION UNIT
K953162 · Olympus America, Inc. · Dec 1995
ELECTRONIC LAPAROFLATOR
K951694 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR
K951961 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
3000 ELECTRONIC INSUFFLATOR MODIFICATION
K934115 · Cabot Medical Corp. · Mar 1995
MODEL 2231 CO2 INSUFFLATOR
K934884 · Richard Wolf Medical Instruments Corp. · Feb 1995
DEXIDE INSUFFLATION TUBING WITH FILTER
K944509 · Dexide, Inc. · Feb 1995