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)

DISPOSABLE UROSTOMY POUCH

K-Number: K850750 · 1985-05-23

ApplicantBiolog, Inc.
Decision Date1985-05-23
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE UROSTOMY POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Biolog, Inc.. It received FDA 510(k) clearance on 1985-05-23 under 510(k) number K850750. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE UROSTOMY POUCH?

DISPOSABLE UROSTOMY POUCH is a medical device that received FDA 510(k) clearance on 1985-05-23. The listed applicant is Biolog, Inc.. The 510(k) number is K850750.

When did DISPOSABLE UROSTOMY POUCH receive FDA 510(k) clearance?

DISPOSABLE UROSTOMY POUCH received FDA 510(k) clearance on 1985-05-23, under 510(k) number K850750.

Who is the listed applicant for DISPOSABLE UROSTOMY POUCH?

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

What is the FDA product code for DISPOSABLE UROSTOMY POUCH?

The FDA product code for DISPOSABLE UROSTOMY POUCH is EXB.

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 Biolog, 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.

K850751DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMYK811283JEMBEC TRANSPORT SYSTEMK811284GC TTANSPORT SYSTEMK811281GC CULTURE MEDIUMK811282SELECTIVE GC CULTURE MEDIUM

Related Devices (Code: EXB)

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.

K252140Heylo™ SystemColoplast Corp.K181643SmartBag (SmartPouch)11 Health Technologies LimitedK922730LAKE OSTOMY CARE SETLake Medical Products, Inc.K882878ODOR-END EMERGENCY CLEAN UP POWDERCdc Products Corp.K881636CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)Coloplast A/SK880306EMERGENCY-CLEAN UP(TM) ECPCdc Products Corp.

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.

↑