510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231277Substantially Equivalent

TissueStat

DuraStat, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231277 is the FDA 510(k) clearance record for TissueStat, a class II device, cleared for Durastat, LLC on under FDA product code NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene). FDA records list one 510(k) clearance for Durastat, LLC. As of , FDA records show no recalls naming K231277.

Clearance record

Decision date
Received
(190 days to decision)
Product code
NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Regulation
21 CFR 878.5035
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Durastat, LLC 1101 E. 6th St., Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBY

Trailing 12 months

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

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