Cleared Traditional

K780484 - SILASTIC BRAND PENILE IMPLANT

K780484 is an FDA 510(k) clearance for SILASTIC BRAND PENILE IMPLANT, manufactured by Dow Corning Corp. Healthcare Industries Materials. The device is a Class 2 Gastroenterology & Urology device with product code FIQ cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K780484 · Dow Corning Corp. Healthcare Industries Materials · Gastroenterology & Urology device
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Jul 1978
Decision
112d
Days
Class 2
Risk

K780484 is an FDA 510(k) clearance for the SILASTIC BRAND PENILE IMPLANT. Classified as Cannula, A-v Shunt (product code FIQ), Class II - Special Controls.

Submitted by Dow Corning Corp. Healthcare Industries Materials (Mchenry, US). The FDA issued a Cleared decision on July 17, 1978 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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: 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.

View all Dow Corning Corp. Healthcare Industries Materials devices

FDA 510(k) Submission Details - K780484

510(k) Number K780484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1978
Decision Date July 17, 1978
Days to Decision 112 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 130d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIQ Device Classification - Class 2, Special Controls

Product Code FIQ Cannula, A-v Shunt
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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.