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FDA 510(k)

ROCAMED ROCAUS PLATINUM

K-Number: K120160 · 2012-05-14

ApplicantPromepla Sam
Decision Date2012-05-14
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ROCAMED ROCAUS PLATINUM is the device name listed in this FDA 510(k) record. The listed applicant is Promepla Sam. It received FDA 510(k) clearance on 2012-05-14 under 510(k) number K120160. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCAMED ROCAUS PLATINUM?

ROCAMED ROCAUS PLATINUM is a medical device that received FDA 510(k) clearance on 2012-05-14. The listed applicant is Promepla Sam. The 510(k) number is K120160.

When did ROCAMED ROCAUS PLATINUM receive FDA 510(k) clearance?

ROCAMED ROCAUS PLATINUM received FDA 510(k) clearance on 2012-05-14, under 510(k) number K120160.

Who is the listed applicant for ROCAMED ROCAUS PLATINUM?

The FDA 510(k) record lists Promepla Sam as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROCAMED ROCAUS PLATINUM?

The FDA product code for ROCAMED ROCAUS PLATINUM is KNY.

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Other records listing Promepla Sam as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182144Bi-Flex EvoK173734RocaJJ Soft StentsK152278ENDOFLOW II - Irrigation, Warming and Suction System

Related Devices (Code: KNY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.K182144Bi-Flex EvoPromepla SamK162356Vesair Cystoscopic SheathSolace TherapeuticsK131803GUARDIAN URETHRAL SHEATHSolace TherapeuticsK123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies AmericaK112209PREFILLED CATHETER INFLATION SYRINGEAvail Medical Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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