510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020077Substantially Equivalent

Modification to Augustine Medical Wound Care System, Model 68Xxx

Augustine Medical, Inc., Eden Prairie MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020077 is the FDA 510(k) clearance record for MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX, a class I device, cleared for Augustine Medical, Inc. on under FDA product code MSA (Dressing, Wound And Burn, Occlusive, Heated). FDA records list 25 510(k) clearances for Augustine Medical, Inc., from to . As of , FDA records show no recalls naming K020077.

Clearance record

Decision date
Received
(22 days to decision)
Product code
MSA Dressing, Wound And Burn, Occlusive, Heated
Regulation
21 CFR 878.4020
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Augustine Medical, Inc. 10393 W. 70th St., Eden Prairie MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSA

Trailing 12 months

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

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