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)

Glo-Tip Spray Catheter

K-Number: K182319 · 2019-02-01

ApplicantWilson-Cook Medical, Inc.
Decision Date2019-02-01
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Glo-Tip Spray Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2019-02-01 under 510(k) number K182319. 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 Glo-Tip Spray Catheter?

Glo-Tip Spray Catheter is a medical device that received FDA 510(k) clearance on 2019-02-01. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K182319.

When did Glo-Tip Spray Catheter receive FDA 510(k) clearance?

Glo-Tip Spray Catheter received FDA 510(k) clearance on 2019-02-01, under 510(k) number K182319.

Who is the listed applicant for Glo-Tip Spray Catheter?

The FDA 510(k) record lists Wilson-Cook Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Glo-Tip Spray Catheter?

The FDA product code for Glo-Tip Spray Catheter is OCX.

Other records listing Wilson-Cook Medical, Inc. 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.

K253302Hemospray Endoscopic Hemostat (HEMO-[X])K251104SureTome™ SW Sphincterotome with DomeTipK243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordK213483SnapLoc Wire LockK213356Entuit PEG, Entuit PEGJK212323Instinct Plus Endoscopic Clipping Device

View all 34 devices →

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.

↑