Cleared Traditional

K120160 - ROCAMED ROCAUS PLATINUM

K120160 is an FDA 510(k) clearance for ROCAMED ROCAUS PLATINUM, manufactured by Promepla Sam. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K120160 · Promepla Sam · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
116d
Days
Class 2
Risk

K120160 is an FDA 510(k) clearance for the ROCAMED ROCAUS PLATINUM. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Promepla Sam (Monaco, MC). The FDA issued a Cleared decision on May 14, 2012 after a review of 116 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Promepla Sam devices

FDA 510(k) Submission Details - K120160

510(k) Number K120160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2012
Decision Date May 14, 2012
Days to Decision 116 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
15d faster than avg
Panel avg: 131d · This submission: 116d
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 41
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K120160.
GUARDIAN URETHRAL SHEATH
K141252 · Solace Therapeutics · Jun 2014
GUARDIAN URETHRAL SHEATH
K131803 · Solace Therapeutics · Aug 2013
VARI-PASS VARIABLE LENGTH ACCESS SHEATH
K123170 · Olympus Surgical Technologies America · Feb 2013
PREFILLED CATHETER INFLATION SYRINGE
K112209 · Avail Medical Products, Inc. · Sep 2011
UROPASS URETERAL ACCESS SHEATH, MODEL 61224
K051593 · Acmi Corporation · Sep 2005
UPDATED SLIP UROLOGY INTRODUCER SHEATH
K042531 · Percutaneous Systems, Incorporated · Feb 2005