510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K904111Substantially Equivalent

Htr Polymer, Htr-Mx

United States Surgical, A Division of Tyco Healthc, Norwalk CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904111 is the FDA 510(k) clearance record for HTR POLYMER, HTR-MX, a class II device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction). FDA records list 218 510(k) clearances for United States Surgical, A Division of Tyco Healthc, from to . As of , FDA records show no recalls naming K904111.

Clearance record

Decision date
Received
(78 days to decision)
Product code
KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Regulation
21 CFR 878.3500
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
United States Surgical, A Division of Tyco Healthc 150 Glover Ave., Norwalk CT
Third party review
No

Clearances, product code KKY

Trailing 12 months

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

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