510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K954674Substantially Equivalent

P1op2b or P1o92t

Kay Borch A/S, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954674 is the FDA 510(k) clearance record for P1OP2B OR P1O92T, a class II device, cleared for Kay Borch A/S on under FDA product code FYA (Gown, Surgical). FDA records list one 510(k) clearance for Kay Borch A/S. As of , FDA records show no recalls naming K954674.

Clearance record

Decision date
Received
(478 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kay Borch A/S 15135 Memorial Dr., Houston TX
510(k) summary
Statement
Third party review
No

Clearances, product code FYA

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