Cleared Traditional

DEVICE FOR THE TREATMENT OF HEMORRHOIDS (K822649) - FDA 510(k) Clearance

K822649 · Dunmore Corp. · Gastroenterology & Urology device
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Nov 1982
Decision
63d
Days
-
Risk

K822649 is an FDA 510(k) clearance for the DEVICE FOR THE TREATMENT OF HEMORRHOIDS. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by Dunmore Corp. (Walker, US). The FDA issued a Cleared decision on November 3, 1982 after a review of 63 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dunmore Corp. devices

Submission Details

510(k) Number K822649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1982
Decision Date November 03, 1982
Days to Decision 63 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 130d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKX Device, Thermal, Hemorrhoids
Device Class -