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)

SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF

K-Number: K904299 · 1990-11-27

ApplicantE-Z-Em, Inc.
Decision Date1990-11-27
Product CodeFGD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1990-11-27 under 510(k) number K904299. The device is classified under product code FGD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF?

SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF is a medical device that received FDA 510(k) clearance on 1990-11-27. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K904299.

When did SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF receive FDA 510(k) clearance?

SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF received FDA 510(k) clearance on 1990-11-27, under 510(k) number K904299.

Who is the listed applicant for SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF?

The FDA 510(k) record lists E-Z-Em, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF?

The FDA product code for SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF is FGD.

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 E-Z-Em, 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.

K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESK062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730K063029EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900K053008E-Z-EM ENDOSCOPIC CO2 REGULATORK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

View all 56 devices →

Related Devices (Code: FGD)

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.

K223890NAJA Gastrointestinal CatheterChess Medical, Inc.K905026DUAL FLEX NON-LATEXMmi, Inc.K905574SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFFE-Z-Em, Inc.K884379MAGLINTE ENTEROCLYSIS CATHETERLafayette Pharmacal, Inc.K872006DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFFMac Lee Medical Products

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.

↑