Cleared Traditional

K840266 - K-FLEX OSTOMY POUCH (FDA 510(k) Clearance)

K840266 · Coloplast A/S · Gastroenterology & Urology device
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Jan 1984
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K840266 is an FDA 510(k) clearance for the K-FLEX OSTOMY POUCH.

Submitted by Coloplast A/S (Mchenry, US). The FDA issued a Cleared decision on January 23, 1984.

This device falls under the Gastroenterology & Urology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K840266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received January 23, 1984
Decision Date January 23, 1984
Days to Decision -
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -