510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982082Substantially Equivalent

Handisol Wound Healing

National Biological Corp., Twinsburg OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982082 is the FDA 510(k) clearance record for HANDISOL WOUND HEALING, a class II device, cleared for National Biological Corp. on under FDA product code FTC (Light, Ultraviolet, Dermatological). FDA records list 28 510(k) clearances for National Biological Corp., from to . As of , FDA records show no recalls naming K982082.

Clearance record

Decision date
Received
(135 days to decision)
Product code
FTC Light, Ultraviolet, Dermatological
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
National Biological Corp. 1532 Enterprise Pkwy., Twinsburg OH
510(k) summary
Summary
Third party review
No

Clearances, product code FTC

Trailing 12 months
2 clearances under product code FTC in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FTC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260