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510(k) K232593

FITme Customized Silicone Implant by Keosan Trading Co. — Product Code FWP

K232593 is an FDA 510(k) premarket notification submitted by Keosan Trading Co. for the device "FITme Customized Silicone Implant". The FDA issued a decision of Substantially Equivalent on November 22, 2023. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Keosan Trading Co. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2023
Date Received
August 25, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Chin, Internal
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type

Other clearances by Keosan Trading Co.

  • K241150 — MISTI Silicone Implant (July 24, 2024)

Other clearances for product code FWP

  • K254233 — MEDPOR Customized Implant Kit (March 12, 2026)
  • K200610 — Customized Contour Implant (December 23, 2020)
  • K191130 — Customized Contour Implant (August 23, 2019)
  • K191916 — Stryker CMF MEDPOR Priority Customized Implant Kit (August 15, 2019)
  • K153508 — Stryker CMF MEDPOR Customized Implant (February 5, 2016)
  • K152463 — SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant (January 20, 2016)
  • K143173 — Stryker CMF MEDPOR Customized Implant (March 23, 2015)
  • K141027 — 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, S (July 10, 2014)
  • K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (November 1, 2012)
  • K091011 — PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) (April 22, 2009)

FDA data resources