510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904535Substantially Equivalent

Lu-Tex II

Lukens Medical Corp., Rio Rancho NM / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904535 is the FDA 510(k) clearance record for LU-TEX II, a class II device, cleared for Lukens Medical Corp. on under FDA product code GAS (Suture, Nonabsorbable, Synthetic, Polyester). FDA records list 8 510(k) clearances for Lukens Medical Corp., from to . As of , FDA records show no recalls naming K904535.

Clearance record

Decision date
Received
(118 days to decision)
Product code
GAS Suture, Nonabsorbable, Synthetic, Polyester
Regulation
21 CFR 878.5000
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Lukens Medical Corp. 500 Laser Rd., Rio Rancho NM
Third party review
No

Clearances, product code GAS

Trailing 12 months

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

FDA records show no clearances under product code GAS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAS, 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