Rocamed Rocaus Platinum

FDA 510(k) K120160 · Promepla Sam

Substantially Equivalent

510(k) numberK120160

Submission

Device name
Rocamed Rocaus Platinum
Applicant
Promepla Sam
Monaco, MC
Received
January 19, 2012
Decision date
May 14, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KNY – Accessories, Catheter, G-U
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

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K162356Vesair Cystoscopic SheathKNY · Special Solace Therapeutics03/02/2017SE
K140441Bi-Flex Ureteral Access SheathKNY · Traditional Promepla Sam06/17/2014SE
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K131803Guardian Urethral SheathKNY · Special Solace Therapeutics08/20/2013SE
K123170Vari-Pass Variable Length Access SheathKNY · Special Olympus Surgical Technologies America02/04/2013SE
K112209Prefilled Catheter Inflation SyringeKNY · Special Avail Medical Products, Inc.09/08/2011SE
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More from Avail Medical Products, Inc.

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K140441Bi-Flex Ureteral Access SheathKNY · Traditional 06/17/2014SE

Questions and answers

When was Rocamed Rocaus Platinum cleared by the FDA?

Rocamed Rocaus Platinum (K120160) received a 510(k) decision of Substantially Equivalent on May 14, 2012, 116 days after the submission was received.

What is the product code of K120160?

The FDA product code is KNY – Accessories, Catheter, G-U, a Class II (moderate risk) device regulated under 21 CFR 876.5130.