FDA 510(k)

K-FLEX OSTOMY POUCH

K-Number: K840266 · 1984-01-23

Decision Date1984-01-23

Product Code

DecisionUnknown

Device Summary

K-FLEX OSTOMY POUCH 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 1984-01-23 under 510(k) number K840266. FDA Decision: Unknown.

Frequently Asked Questions

What is the K-FLEX OSTOMY POUCH?

K-FLEX OSTOMY POUCH is a medical device that received FDA 510(k) clearance on 1984-01-23. The listed applicant is Coloplast A/S. The 510(k) number is K840266.

When did K-FLEX OSTOMY POUCH receive FDA 510(k) clearance?

K-FLEX OSTOMY POUCH received FDA 510(k) clearance on 1984-01-23, under 510(k) number K840266.

Who is the listed applicant for K-FLEX OSTOMY POUCH?

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

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Coloplast A/S as applicant

K262045Luja Soft K221874Altis Single Incision Sling System K220420Saffron Fixation System K191536Biatain Silicone Ag K181811ReTrace Ureteral Access Sheath K173527Digitex Delivery Device

View all 66 devices →

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.