Cleared Traditional

K860192 - ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE

K860192 is an FDA 510(k) clearance for ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE, manufactured by Endotherapeutics. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K860192 · Endotherapeutics · Obstetrics & Gynecology device
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Mar 1986
Decision
54d
Days
Class 2
Risk

K860192 is an FDA 510(k) clearance for the ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Endotherapeutics (Redwood City, US). The FDA issued a Cleared decision on March 17, 1986 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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 Endotherapeutics devices

FDA 510(k) Submission Details - K860192

510(k) Number K860192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1986
Decision Date March 17, 1986
Days to Decision 54 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 160d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 - HET Laparoscope, Gynecologic (and Accessories)

All 228
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K860192.
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