510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923187Substantially Equivalent

Impervious Isolation Shoe Covers

Dynatech Medical Products, Rockwall TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923187 is the FDA 510(k) clearance record for IMPERVIOUS ISOLATION SHOE COVERS, a class I device, cleared for Dynatech Medical Products on under FDA product code FXW (Shoes, Operating-Room). FDA records list 5 510(k) clearances for Dynatech Medical Products, from to . As of , FDA records show no recalls naming K923187.

Clearance record

Decision date
Received
(213 days to decision)
Product code
FXW Shoes, Operating-Room
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Dynatech Medical Products 605 White Hills Dr., Rockwall TX
510(k) summary
Statement
Third party review
No

Clearances, product code FXW

Trailing 12 months

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

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