510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K020276Substantially Equivalent

8 Gauge Micromark II Tissue Marker, Models C1540 & C1535

Ethicon Endo-Surgery Inc, Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020276 is the FDA 510(k) clearance record for 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535, a class II device, cleared for Ethicon Endo-Surgery, Inc. on under FDA product code NEU (Marker, Radiographic, Implantable). FDA records list 185 510(k) clearances for Ethicon Endo-Surgery, Inc., from to . As of , FDA records show no recalls naming K020276.

Clearance record

Decision date
Received
(74 days to decision)
Product code
NEU Marker, Radiographic, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Ethicon Endo-Surgery, Inc. 4545 Creek Rd., Cincinnati OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NEU

Trailing 12 months
4 clearances under product code NEU in the twelve months to November 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code NEU, trailing twelve months
MonthClearances
December 20253
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260