Cleared Traditional

Pre-Formed Penile Silicone Block

K220760 · International Medical Devices, Inc. · General & Plastic Surgery

May 2022

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K220760 is an FDA 510(k) clearance for the Pre-Formed Penile Silicone Block, a Elastomer, Silicone Block (Class II — Special Controls, product code MIB), submitted by International Medical Devices, Inc. (Beverly Hills, US). The FDA issued a Cleared decision on May 13, 2022, 59 days after receiving the submission on March 15, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number	K220760 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 2022
Decision Date	May 13, 2022
Days to Decision	59 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF