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)

ORIGEN BLADDER HOLDER

K-Number: K003145 · 2001-04-20

ApplicantOrigen Biomedical, Inc.
Decision Date2001-04-20
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ORIGEN BLADDER HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Origen Biomedical, Inc.. It received FDA 510(k) clearance on 2001-04-20 under 510(k) number K003145. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORIGEN BLADDER HOLDER?

ORIGEN BLADDER HOLDER is a medical device that received FDA 510(k) clearance on 2001-04-20. The listed applicant is Origen Biomedical, Inc.. The 510(k) number is K003145.

When did ORIGEN BLADDER HOLDER receive FDA 510(k) clearance?

ORIGEN BLADDER HOLDER received FDA 510(k) clearance on 2001-04-20, under 510(k) number K003145.

Who is the listed applicant for ORIGEN BLADDER HOLDER?

The FDA 510(k) record lists Origen Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORIGEN BLADDER HOLDER?

The FDA product code for ORIGEN BLADDER HOLDER is DWC.

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 Origen Biomedical, 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.

K113869ORIGEN REINFORCED DUAL LUMEN CATHETERK021702CRYOBAG, MODEL CBK003288ORIGEN DUAL LUMEN CATHETER

Related Devices (Code: DWC)

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.

K220635Heater-Cooler System 3TLivanova Deutschland, GmbHK212657Quantum Heater-CoolerSpectrum Medical , Ltd.K191402Heater-Cooler System 3TLivanova Deutschland, GmbHK130300HEATER-COOLER UNIT HCU 40Maquet Cardiopulmonary, AGK122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMCincinnati Sub-Zero Products, Inc.K102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000Cardioquip Llp

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.

↑