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FDA 510(k)

FITme Customized Silicone Implant

K-Number: K232593 · 2023-11-22

ApplicantKeosan Trading Co.
Decision Date2023-11-22
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FITme Customized Silicone Implant is a medical device manufactured by Keosan Trading Co.. It received FDA 510(k) clearance on 2023-11-22 under approval number K232593. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FITme Customized Silicone Implant?

FITme Customized Silicone Implant is a medical device that received FDA 510(k) clearance on 2023-11-22. It is manufactured by Keosan Trading Co.. The 510(k) number is K232593.

When was FITme Customized Silicone Implant approved by the FDA?

FITme Customized Silicone Implant received FDA 510(k) clearance on 2023-11-22, under approval number K232593.

What company makes FITme Customized Silicone Implant?

FITme Customized Silicone Implant is manufactured by Keosan Trading Co..

What is the FDA product code for FITme Customized Silicone Implant?

The FDA product code for FITme Customized Silicone Implant is FWP.

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT05683106 Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy COMPLETED NCT04985123 A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery COMPLETED

Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026)

Other Devices by Keosan Trading Co.

K241150MISTI Silicone Implant

Related Devices (Code: FWP)

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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.

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