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FDA 510(k)

TRAY, BLADDER IRRIGATION

K-Number: K760047 · 1977-03-01

ApplicantM-C Ind., Inc.
Decision Date1977-03-01
Product CodeEYN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRAY, BLADDER IRRIGATION is the device name listed in this FDA 510(k) record. The listed applicant is M-C Ind., Inc.. It received FDA 510(k) clearance on 1977-03-01 under 510(k) number K760047. The device is classified under product code EYN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAY, BLADDER IRRIGATION?

TRAY, BLADDER IRRIGATION is a medical device that received FDA 510(k) clearance on 1977-03-01. The listed applicant is M-C Ind., Inc.. The 510(k) number is K760047.

When did TRAY, BLADDER IRRIGATION receive FDA 510(k) clearance?

TRAY, BLADDER IRRIGATION received FDA 510(k) clearance on 1977-03-01, under 510(k) number K760047.

Who is the listed applicant for TRAY, BLADDER IRRIGATION?

The FDA 510(k) record lists M-C Ind., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRAY, BLADDER IRRIGATION?

The FDA product code for TRAY, BLADDER IRRIGATION is EYN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing M-C Ind., 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.

K760048TRAY, URETHRAL CATHETERIZATIONK760051TRAY, SUTURE REMOVALK760052KIT, PREP SHAVE

Related Devices (Code: EYN)

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.

K944882IRRIGATION TRAYClinical Resources, Inc.K923940IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINEAmerican Healthcare Corp.K923939IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATERAmerican Healthcare Corp.K923938IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATERAmerican Healthcare Corp.K923941IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINEAmerican Healthcare Corp.K900148KIT PAK IRRIGATION TRAYKit Pak, Inc.

Official Source

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

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