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)

San Antonio Stopcock

K-Number: K181712 · 2018-07-26

ApplicantCook Incorporated
Decision Date2018-07-26
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

San Antonio Stopcock is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-07-26 under 510(k) number K181712. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the San Antonio Stopcock?

San Antonio Stopcock is a medical device that received FDA 510(k) clearance on 2018-07-26. The listed applicant is Cook Incorporated. The 510(k) number is K181712.

When did San Antonio Stopcock receive FDA 510(k) clearance?

San Antonio Stopcock received FDA 510(k) clearance on 2018-07-26, under 510(k) number K181712.

Who is the listed applicant for San Antonio Stopcock?

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

What is the FDA product code for San Antonio Stopcock?

The FDA product code for San Antonio Stopcock is ODC.

Other records listing Cook Incorporated 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.

PMA P020018SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTK233177Nest VT Vitrification DeviceK222254Gunther Tulip Vena Cava Filter Retrieval SetK223098Bakri Essential Postpartum BalloonK210734Endovascular Dilator and SetsK203670Extra Large Check-Flo Introducer

View all 147 devices →

Related Devices (Code: ODC)

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.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

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.

↑