510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821178Substantially Equivalent

Ethicon External Fixation Wire

Ethicon, Inc, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821178 is the FDA 510(k) clearance record for ETHICON EXTERNAL FIXATION WIRE, a class I device, cleared for ETHICON, Inc. on under FDA product code FYI (Appliance, Facial Fracture, External). FDA records list 208 510(k) clearances for ETHICON, Inc., from to . As of , FDA records show no recalls naming K821178.

Clearance record

Decision date
Received
(410 days to decision)
Product code
FYI Appliance, Facial Fracture, External
Regulation
21 CFR 878.3250
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
ETHICON, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FYI

Trailing 12 months

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

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