510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K914702Substantially Equivalent

Sterile View(tm) Knee-High Boots/depuy Shoe Boots

Depuy, Inc., Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914702 is the FDA 510(k) clearance record for STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS, a class I device, cleared for Depuy, Inc. on under FDA product code FXP (Cover, Shoe, Operating-Room). FDA records list 220 510(k) clearances for Depuy, Inc., from to . As of , FDA records show no recalls naming K914702.

Clearance record

Decision date
Received
(469 days to decision)
Product code
FXP Cover, Shoe, Operating-Room
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Depuy, Inc. P.O. Box 988, Warsaw IN
510(k) summary
Summary
Third party review
No

Clearances, product code FXP

Trailing 12 months

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

FDA records show no clearances under product code FXP in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FXP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260