510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K923408Substantially Equivalent

Wrappel T

Standard Textile Co., Inc., Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923408 is the FDA 510(k) clearance record for WRAPPEL T, a class II device, cleared for Standard Textile Co., Inc. on under FDA product code FRG (Wrap, Sterilization). FDA records list 23 510(k) clearances for Standard Textile Co., Inc., from to . As of , FDA records show no recalls naming K923408.

Clearance record

Decision date
Received
(272 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Standard Textile Co., Inc. One Knollcrest Dr., Cincinnati OH
510(k) summary
Summary
Third party review
No

Clearances, product code FRG

Trailing 12 months
5 clearances under product code FRG in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FRG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260