Cleared Traditional

K052134 - CYSTOGLIDE DILATING INTRODUCER SHEATH

K052134 is an FDA 510(k) clearance for CYSTOGLIDE DILATING INTRODUCER SHEATH, manufactured by Percutaneous Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K052134 · Percutaneous Systems, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 2005
Decision
48d
Days
Class 2
Risk

K052134 is an FDA 510(k) clearance for the CYSTOGLIDE DILATING INTRODUCER SHEATH. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Percutaneous Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 22, 2005 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Percutaneous Systems, Inc. devices

FDA 510(k) Submission Details - K052134

510(k) Number K052134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2005
Decision Date September 22, 2005
Days to Decision 48 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 131d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNY Accessories, Catheter, G-u

All 46
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K052134.
CYSTOGLIDE INTRODUCER SHEATH
K052298 · Percutaneous Systems, Incorporated · Dec 2006
CAREVENT
K062240 · Chief Medical, LLC · Oct 2006
CATHASSIST
K052952 · Physician Technologies, Inc. · May 2006
UROPASS URETERAL ACCESS SHEATH, MODEL 61224
K051593 · Acmi Corporation · Sep 2005
UPDATED SLIP UROLOGY INTRODUCER SHEATH
K042531 · Percutaneous Systems, Incorporated · Feb 2005
MICROVERTER URETERAL ACCESS SHEATH
K042877 · Percutaneous Systems, Inc. · Nov 2004