510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082208Substantially Equivalent

Doctors Choice Slow Healing Bandage with Spray on Remover

Scivolutions, Inc., Appollo Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082208 is the FDA 510(k) clearance record for DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER, a class I device, cleared for Scivolutions, Inc. on under FDA product code NAC (Dressing, Wound, Hydrophilic). FDA records list 2 510(k) clearances for Scivolutions, Inc., from to . As of , FDA records show no recalls naming K082208.

Clearance record

Decision date
Received
(118 days to decision)
Product code
NAC Dressing, Wound, Hydrophilic
Regulation
21 CFR 878.4018
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Scivolutions, Inc. 962 Allegro Ln., Appollo Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NAC

Trailing 12 months

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

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