510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934842Substantially Equivalent

Tecnol Splashguard

Tecnol Medical Products, Inc., Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934842 is the FDA 510(k) clearance record for TECNOL SPLASHGUARD, a class I device, cleared for Tecnol Medical Products, Inc. on under FDA product code LYU (Accessory, Surgical Apparel). FDA records list 21 510(k) clearances for Tecnol Medical Products, Inc., from to . As of , FDA records show no recalls naming K934842.

Clearance record

Decision date
Received
(152 days to decision)
Product code
LYU Accessory, Surgical Apparel
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Tecnol Medical Products, Inc. 7201 Industrial Park Blvd., Fort Worth TX
510(k) summary
Statement
Third party review
No

Clearances, product code LYU

Trailing 12 months

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

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