510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K971680Substantially Equivalent

Auto Suture Bone Wax

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

K971680 is the FDA 510(k) clearance record for AUTO SUTURE BONE WAX, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code MTJ (Wax, Bone). 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 K971680.

Clearance record

Decision date
Received
(170 days to decision)
Product code
MTJ Wax, Bone
Device class
Unclassified
Review panel
Unknown
Applicant
United States Surgical, A Division of Tyco Healthc 150 Glover Ave., Norwalk CT
510(k) summary
Summary
Third party review
No

Clearances, product code MTJ

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