510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973552Substantially Equivalent

Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap

Bio-Vascular, Inc., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973552 is the FDA 510(k) clearance record for OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP, a class II device, cleared for Bio-Vascular, Inc. on under FDA product code MTZ (Wrap, Implant, Orbital). FDA records list 26 510(k) clearances for Bio-Vascular, Inc., from to . As of , FDA records show no recalls naming K973552.

Clearance record

Decision date
Received
(88 days to decision)
Product code
MTZ Wrap, Implant, Orbital
Regulation
21 CFR 886.3320
Device class
Class II
Review panel
Ophthalmic
Applicant
Bio-Vascular, Inc. 2575 University Ave., St. Paul MN
510(k) summary
Summary
Third party review
No

Clearances, product code MTZ

Trailing 12 months

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

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