510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812291Substantially Equivalent

Ethicon Multiple Ligating Clip Applier

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

K812291 is the FDA 510(k) clearance record for ETHICON MULTIPLE LIGATING CLIP APPLIER, a class I device, cleared for ETHICON, Inc. on under FDA product code GDO (Applier, Surgical, Clip). FDA records list 208 510(k) clearances for ETHICON, Inc., from to . As of , FDA records show 3 recalls naming K812291.

Clearance record

Decision date
Received
(29 days to decision)
Product code
GDO Applier, Surgical, Clip
Regulation
21 CFR 878.4800
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 GDO

Trailing 12 months

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

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