510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213198Substantially Equivalent

Ax-Surgi Surgical Hemostat

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

K213198 is the FDA 510(k) clearance record for Ax-Surgi Surgical Hemostat, a class II device, cleared for Advamedica, Inc. on under FDA product code POD (Temporary, Internal Use Hemostatic). FDA's definition for product code POD reads: "Intended to control severely bleeding wounds". FDA records list 5 510(k) clearances for Advamedica, Inc., from to . As of , FDA records show no recalls naming K213198.

Clearance record

Decision date
Received
(463 days to decision)
Product code
POD Temporary, Internal Use Hemostatic
Regulation
21 CFR 878.4454
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Advamedica, Inc. Harvard Sq. 1, Mifflin Pl.,, Cambridge MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code POD

Trailing 12 months

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

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