510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K965045Substantially Equivalent

Tristar Lp Torcar with Low Profile Threaded Sleeve

Ethicon Endo-Surgery Inc, Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965045 is the FDA 510(k) clearance record for TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE, a class II device, cleared for Ethicon Endo-Surgery, Inc. on under FDA product code HET (Laparoscope, Gynecologic (And Accessories)). FDA records list 185 510(k) clearances for Ethicon Endo-Surgery, Inc., from to . As of , FDA records show no recalls naming K965045.

Clearance record

Decision date
Received
(139 days to decision)
Product code
HET Laparoscope, Gynecologic (And Accessories)
Regulation
21 CFR 884.1720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Ethicon Endo-Surgery, Inc. 4545 Creek Rd., Cincinnati OH
510(k) summary
Summary
Third party review
No

Clearances, product code HET

Trailing 12 months

FDA records hold no clearances under product code HET in the trailing twelve months.

FDA records show no clearances under product code HET in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HET, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260