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FDA 510(k)

DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY

K-Number: K850751 · 1985-05-23

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

Device Summary

DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY 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 K850751. 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 DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY?

DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY 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 K850751.

When did DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY receive FDA 510(k) clearance?

DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY received FDA 510(k) clearance on 1985-05-23, under 510(k) number K850751.

Who is the listed applicant for DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY?

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 DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY?

The FDA product code for DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY 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.

K850750DISPOSABLE UROSTOMY POUCHK811283JEMBEC 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

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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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