Cleared Traditional

K162624 - Pre-Formed Penile Silicone Block

K162624 is an FDA 510(k) clearance for Pre-Formed Penile Silicone Block, manufactured by International Medical Devices, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MIB cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K162624 · International Medical Devices, Inc. · General & Plastic Surgery device
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Feb 2017
Decision
134d
Days
Class 2
Risk

K162624 is an FDA 510(k) clearance for the Pre-Formed Penile Silicone Block. Classified as Elastomer, Silicone Block (product code MIB), Class II - Special Controls.

Submitted by International Medical Devices, Inc. (Beverly Hills, US). The FDA issued a Cleared decision on February 1, 2017 after a review of 134 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 874.3620 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all International Medical Devices, Inc. devices

FDA 510(k) Submission Details - K162624

510(k) Number K162624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2016
Decision Date February 01, 2017
Days to Decision 134 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 115d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MIB Device Classification - Class 2, Special Controls

Product Code MIB Elastomer, Silicone Block
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - MIB Elastomer, Silicone Block

All 11
Devices cleared under the same product code (MIB) and FDA review panel - the closest regulatory comparables to K162624.
BioSiCar Silicone Implant
K193392 · Metalware Technology Corp. · Jul 2020
Pre-Formed Penile Silicone Block
K181387 · International Medical Devices, Inc. · Jan 2019
SOFTXIL
K171851 · Bistool · Mar 2018
GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
K052504 · Implantech Associates, Inc. · Nov 2005
CALF IMPLANT, MODEL EC17-X
K052505 · Implantech Associates, Inc. · Nov 2005
ZARA SILICONE BLOCK
K913882 · Byron Medical · Apr 1992