510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896806Substantially Equivalent

Catheter Plug/protector

Westmark, Sterile Packing Systems, Inc. (Sps), Grand Rapids MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896806 is the FDA 510(k) clearance record for CATHETER PLUG/PROTECTOR, a class II device, cleared for Westmark, Sterile Packing Systems, Inc. (Sps) on under FDA product code KNY (Accessories, Catheter, G-U). FDA records list 28 510(k) clearances for Westmark, Sterile Packing Systems, Inc. (Sps), from to . As of , FDA records show no recalls naming K896806.

Clearance record

Decision date
Received
(87 days to decision)
Product code
KNY Accessories, Catheter, G-U
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Westmark, Sterile Packing Systems, Inc. (Sps) 1253 Ramona St. SE, Grand Rapids MI
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