510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K162310Substantially Equivalent

XBraid TT Suture Tape

Stryker Corp., Greenwood Village CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162310 is the FDA 510(k) clearance record for XBraid TT Suture Tape, a class II device, cleared for Stryker on under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). FDA records list 568 510(k) clearances for Stryker, from to . As of , FDA records show no recalls naming K162310.

Clearance record

Decision date
Received
(85 days to decision)
Product code
GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Regulation
21 CFR 878.5000
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Stryker 5670 Greenwood Plz. Blvd. Suite 200, Greenwood Village CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAT

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