Pre-Formed Penile Silicone Block
K-Number: K162624 · 2017-02-01
ApplicantInternational Medical Devices, Inc.
Decision Date2017-02-01
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Pre-Formed Penile Silicone Block is a medical device manufactured by International Medical Devices, Inc.. It received FDA 510(k) clearance on 2017-02-01 under approval number K162624. The device is classified under product code MIB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pre-Formed Penile Silicone Block?
Pre-Formed Penile Silicone Block is a medical device that received FDA 510(k) clearance on 2017-02-01. It is manufactured by International Medical Devices, Inc.. The 510(k) number is K162624.
When was Pre-Formed Penile Silicone Block approved by the FDA?
Pre-Formed Penile Silicone Block received FDA 510(k) clearance on 2017-02-01, under approval number K162624.
What company makes Pre-Formed Penile Silicone Block?
Pre-Formed Penile Silicone Block is manufactured by International Medical Devices, Inc..
What is the FDA product code for Pre-Formed Penile Silicone Block?
The FDA product code for Pre-Formed Penile Silicone Block is MIB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.