510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052134Substantially Equivalent

Cystoglide Dilating Introducer Sheath

Percutaneous Systems, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052134 is the FDA 510(k) clearance record for CYSTOGLIDE DILATING INTRODUCER SHEATH, a class II device, cleared for Percutaneous Systems, Inc. on under FDA product code KNY (Accessories, Catheter, G-U). FDA records list 6 510(k) clearances for Percutaneous Systems, Inc., from to . As of , FDA records show no recalls naming K052134.

Clearance record

Decision date
Received
(48 days to decision)
Product code
KNY Accessories, Catheter, G-U
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Percutaneous Systems, Inc. 1300 Crittenden Ln., Mountain View CA
510(k) summary
Summary PDF
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