Cleared Traditional

ESKA JONAS SILICONE-SILVER PENILE PROST (K820081) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K820081 · Dacomed Corp. · Gastroenterology & Urology device
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Jan 1982
Decision
13d
Days
Class 2
Risk

K820081 is an FDA 510(k) clearance for the ESKA JONAS SILICONE-SILVER PENILE PROST. Classified as Prosthesis, Penile (product code FAE), Class II - Special Controls.

Submitted by Dacomed Corp. (Mchenry, US). The FDA issued a Cleared decision on January 25, 1982 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.3630 - the FDA gastroenterology and urology device framework. 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 Dacomed Corp. devices

Submission Details

510(k) Number K820081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1982
Decision Date January 25, 1982
Days to Decision 13 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
117d faster than avg
Panel avg: 130d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAE Prosthesis, Penile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.3630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.