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510(k) K193392

BioSiCar Silicone Implant by Metalware Technology Corp. — Product Code MIB

K193392 is an FDA 510(k) premarket notification submitted by Metalware Technology Corp. for the device "BioSiCar Silicone Implant". The FDA issued a decision of Substantially Equivalent on July 20, 2020. The device falls under product code MIB (Elastomer, Silicone Block), a Class II device regulated under 21 CFR 874.3620.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2020
Date Received
December 6, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elastomer, Silicone Block
Device Class
Class II
Regulation Number
874.3620
Review Panel
SU
Submission Type

Other clearances for product code MIB

  • K241150 — MISTI Silicone Implant (July 24, 2024)
  • K223051 — Pre-Formed Silicone Block (February 3, 2023)
  • K222748 — ShiNeo Silicone Implant (December 23, 2022)
  • K200073 — AugMENTA Penile Implant (September 30, 2022)
  • K220760 — Pre-Formed Penile Silicone Block (May 13, 2022)
  • K181387 — Pre-Formed Penile Silicone Block (January 23, 2019)
  • K171851 — SOFTXIL (March 16, 2018)
  • K162624 — Pre-Formed Penile Silicone Block (February 1, 2017)
  • K052505 — CALF IMPLANT, MODEL EC17-X (November 4, 2005)
  • K052504 — GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X (November 4, 2005)

FDA data resources