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FDA 510(k)

COLOSTOMY BAG

K-Number: K830841 · 1983-07-19

ApplicantC & D Colostomy Pad Corp.
Decision Date1983-07-19
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLOSTOMY BAG is the device name listed in this FDA 510(k) record. The listed applicant is C & D Colostomy Pad Corp.. It received FDA 510(k) clearance on 1983-07-19 under 510(k) number K830841. 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 COLOSTOMY BAG?

COLOSTOMY BAG is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is C & D Colostomy Pad Corp.. The 510(k) number is K830841.

When did COLOSTOMY BAG receive FDA 510(k) clearance?

COLOSTOMY BAG received FDA 510(k) clearance on 1983-07-19, under 510(k) number K830841.

Who is the listed applicant for COLOSTOMY BAG?

The FDA 510(k) record lists C & D Colostomy Pad Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLOSTOMY BAG?

The FDA product code for COLOSTOMY BAG 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

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.

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