510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121964Substantially Equivalent

Markit Tissue Marker-1Ml Markit Tissue Marker-3Ml Markit Tissue Marker-10Ml

Augmenix, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121964 is the FDA 510(k) clearance record for MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML, a class II device, cleared for Augmenix, Inc. on under FDA product code NEU (Marker, Radiographic, Implantable). FDA records list 5 510(k) clearances for Augmenix, Inc., from to . As of , FDA records show no recalls naming K121964.

Clearance record

Decision date
Received
(202 days to decision)
Product code
NEU Marker, Radiographic, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Augmenix, Inc. 204 Second Ave., Lower Level, Waltham MA
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 October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code NEU, trailing twelve months
MonthClearances
November 20250
December 20253
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260