Cleared Traditional

K965045 - TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE

K965045 is an FDA 510(k) clearance for TRISTAR LP TORCAR WITH LOW PROFILE THRE..., manufactured by Ethicon Endo-Surgery, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K965045 · Ethicon Endo-Surgery, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
139d
Days
Class 2
Risk

K965045 is an FDA 510(k) clearance for the TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 5, 1997 after a review of 139 days - within the typical 510(k) review window.

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: 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.

View all Ethicon Endo-Surgery, Inc. devices

FDA 510(k) Submission Details - K965045

510(k) Number K965045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1996
Decision Date May 05, 1997
Days to Decision 139 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
21d faster than avg
Panel avg: 160d · This submission: 139d
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 199
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K965045.
VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR
K971836 · CooperSurgical, Inc. · Nov 1997
AMR MINI-LAPAROSCOPE
K962777 · Applied Medical Resources · Aug 1997
VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820
K971837 · CooperSurgical, Inc. · Aug 1997
IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
K971255 · Imagyn Medical, Inc. · Apr 1997
CANNULA
K965121 · Origin Medsystems, Inc. · Mar 1997
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K970151 · Smith & Nephew, Inc. · Mar 1997