510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K863570Substantially Equivalent

Le Veen Wound Splint

Tek-Aid, Inc., Charleston SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863570 is the FDA 510(k) clearance record for LE VEEN WOUND SPLINT, a class I device, cleared for Tek-Aid, Inc. on under FDA product code KGS (Retention Device, Suture). FDA records list one 510(k) clearance for Tek-Aid, Inc. As of , FDA records show no recalls naming K863570.

Clearance record

Decision date
Received
(17 days to decision)
Product code
KGS Retention Device, Suture
Regulation
21 CFR 878.4930
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Tek-Aid, Inc. 1023 Wappoo Rd., Suite 41-B, Charleston SC
Third party review
No

Clearances, product code KGS

Trailing 12 months

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

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