510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K072560Substantially Equivalent

Envela (Hydrohesive Occlusive Dressing)

Teikoku Pharma USA, Inc., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072560 is the FDA 510(k) clearance record for ENVELA (HYDROHESIVE OCCLUSIVE DRESSING), a class I device, cleared for Teikoku Pharma USA, Inc. on under FDA product code NAD (Dressing, Wound, Occlusive). FDA records list one 510(k) clearance for Teikoku Pharma USA, Inc. As of , FDA records show no recalls naming K072560.

Clearance record

Decision date
Received
(280 days to decision)
Product code
NAD Dressing, Wound, Occlusive
Regulation
21 CFR 878.4020
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Teikoku Pharma USA, Inc. 1718 Ringwood Ave., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NAD

Trailing 12 months
1 clearance under product code NAD in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NAD, 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 20261
October 20260