510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K913679Substantially Equivalent

Universal Swivel Patch

Bryman Medical, Huntington Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913679 is the FDA 510(k) clearance record for UNIVERSAL SWIVEL PATCH, a class II device, cleared for Bryman Medical on under FDA product code KNY (Accessories, Catheter, G-U). FDA records list one 510(k) clearance for Bryman Medical. As of , FDA records show no recalls naming K913679.

Clearance record

Decision date
Received
(17 days to decision)
Product code
KNY Accessories, Catheter, G-U
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Bryman Medical 8855 Atlanta St., #289, Huntington Beach CA
510(k) summary
Statement
Third party review
No

Clearances, product code KNY

Trailing 12 months
1 clearance under product code KNY in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260