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)

CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)

K-Number: K881636 · 1988-07-13

ApplicantColoplast A/S
Decision Date1988-07-13
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 1988-07-13 under 510(k) number K881636. 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 CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)?

CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) is a medical device that received FDA 510(k) clearance on 1988-07-13. The listed applicant is Coloplast A/S. The 510(k) number is K881636.

When did CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) receive FDA 510(k) clearance?

CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) received FDA 510(k) clearance on 1988-07-13, under 510(k) number K881636.

Who is the listed applicant for CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)?

The FDA product code for CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) 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 Coloplast A/S 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.

K262045Luja SoftK221874Altis Single Incision Sling SystemK220420Saffron Fixation SystemK191536Biatain Silicone AgK181811ReTrace Ureteral Access SheathK173527Digitex Delivery Device

View all 66 devices →

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.K880306EMERGENCY-CLEAN UP(TM) ECPCdc Products Corp.K872294COMBINATION NITE DRAINAGE UNITArnold Technologies

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.

↑