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510(k) K181387

Pre-Formed Penile Silicone Block by International Medical Devices, Inc. — Product Code MIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2019
Date Received
May 25, 2018
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 by International Medical Devices, Inc.

  • K223051 — Pre-Formed Silicone Block (February 3, 2023)
  • K220760 — Pre-Formed Penile Silicone Block (May 13, 2022)
  • K162624 — Pre-Formed Penile Silicone Block (February 1, 2017)

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)
  • K193392 — BioSiCar Silicone Implant (July 20, 2020)
  • 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)