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510(k) K973730

DURASIL I AND DURASIL II by Hanson Medical, Inc. — Product Code MIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1997
Date Received
September 30, 1997
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 Hanson Medical, Inc.

  • K141822 — SENSEI X ROBOTIC CATHETER SYSTEM (August 5, 2014)
  • K090803 — HANSON MEDICAL FACIAL IMPLANTS (June 30, 2010)
  • K071018 — MONARCH NASAL IMPLANT (May 25, 2007)
  • K041690 — MONARCH NASAL IMPLANT (February 11, 2005)
  • K040307 — HANSON SCAR ADE (August 12, 2004)
  • K030808 — HANSON MEDICAL CALF IMPLANT (April 21, 2003)
  • K030809 — HANSON MEDICAL GLUTEAL IMPLANT (April 21, 2003)
  • K973729 — POWERFLEX PEC IMPLANT (December 24, 1997)
  • K973573 — DURALASTIC ANATOMICAL NASAL IMPLANTS (November 13, 1997)
  • K973728 — SILICONE CARVING BLOCK (November 13, 1997)

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)
  • 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)