Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ENDOFLOW II - Irrigation, Warming and Suction System

K-Number: K152278 · 2016-02-09

ApplicantPromepla Sam
Decision Date2016-02-09
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOFLOW II - Irrigation, Warming and Suction System is the device name listed in this FDA 510(k) record. The listed applicant is Promepla Sam. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K152278. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOFLOW II - Irrigation, Warming and Suction System?

ENDOFLOW II - Irrigation, Warming and Suction System is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is Promepla Sam. The 510(k) number is K152278.

When did ENDOFLOW II - Irrigation, Warming and Suction System receive FDA 510(k) clearance?

ENDOFLOW II - Irrigation, Warming and Suction System received FDA 510(k) clearance on 2016-02-09, under 510(k) number K152278.

Who is the listed applicant for ENDOFLOW II - Irrigation, Warming and Suction System?

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 ENDOFLOW II - Irrigation, Warming and Suction System?

The FDA product code for ENDOFLOW II - Irrigation, Warming and Suction System is OCX.

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 Stents

Related Devices (Code: OCX)

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.

K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems CorporationK251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems CorporationK242586ArgoCap (200.52)Ovesco Endoscopy AGK241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems CorporationK241874Aspiration Catheter (2189)Hobbs Medical, 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.

↑