510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101805Unknown

Hydrofix Vaso Shield

Mimedx Group, Inc., Marietta GA / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101805 is the FDA 510(k) clearance record for HYDROFIX VASO SHIELD, a class II device, cleared for Mimedx Group, Inc. on under FDA product code OMR (Vessel Guard Or Cover). FDA's definition for product code OMR reads: "These device types do not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of vascular surgery. Intended to protect vessels from injury during surgery (not to be confused with...". FDA records list 5 510(k) clearances for Mimedx Group, Inc., from to . As of , FDA records show no recalls naming K101805.

Clearance record

Decision date
Received
(284 days to decision)
Product code
OMR Vessel Guard Or Cover
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Applicant
Mimedx Group, Inc. 811 Livingston Ct. SE, Marietta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMR

Trailing 12 months

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

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