510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955810Substantially Equivalent

U-Tex

Abbott Medical, Mississauga, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955810 is the FDA 510(k) clearance record for U-TEX, a class I device, cleared for Laborie Medical Technologies, Ltd. on under FDA product code FHA (Clamp, Penile). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K955810.

Clearance record

Decision date
Received
(29 days to decision)
Product code
FHA Clamp, Penile
Regulation
21 CFR 876.5160
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Laborie Medical Technologies, Ltd. 6415 Northwest Dr., Unit 11, Mississauga, CA
510(k) summary
Statement
Third party review
No

Clearances, product code FHA

Trailing 12 months

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

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