510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K942969Substantially Equivalent

Auto Suture Spinal Nerve Hook

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

K942969 is the FDA 510(k) clearance record for AUTO SUTURE SPINAL NERVE HOOK, a class I device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code HAO (Instrument, Surgical, Non-Powered). 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 K942969.

Clearance record

Decision date
Received
(30 days to decision)
Product code
HAO Instrument, Surgical, Non-Powered
Regulation
21 CFR 882.4535
Device class
Class I
Review panel
Neurology
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 HAO

Trailing 12 months

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

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