510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K091011Substantially Equivalent

Pureform Eptfe Facial Implants (Nasal, Chin, Maler)

Surgical Technology Laboratories, Inc ("Stl"), Columbia SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091011 is the FDA 510(k) clearance record for PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER), a class II device, cleared for Surgical Technology Laboratories, Inc ("Stl") on under FDA product code FWP (Prosthesis, Chin, Internal). FDA records list one 510(k) clearance for Surgical Technology Laboratories, Inc ("Stl"). As of , FDA records show no recalls naming K091011.

Clearance record

Decision date
Received
(13 days to decision)
Product code
FWP Prosthesis, Chin, Internal
Regulation
21 CFR 878.3550
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Surgical Technology Laboratories, Inc ("Stl") 610 Clemson Rd., Columbia SC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FWP

Trailing 12 months
1 clearance under product code FWP in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FWP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260