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510(k) K021839

AART GLUTEAL IMPLANT by Aesthetic and Reconstructive Technologies, Inc. — Product Code MIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2002
Date Received
June 4, 2002
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 Aesthetic and Reconstructive Technologies, Inc.

  • K023678 — DIMISIL SCAR GEL (January 23, 2003)
  • K022306 — AART SILICONE TUBING (October 10, 2002)
  • K022511 — AART CALF IMPLANT (August 26, 2002)
  • K022223 — AART SILICONE SHEETING (August 8, 2002)
  • K021820 — AART SILICONE CARVING BLOCK (July 16, 2002)
  • K021337 — AART PECTORALIS IMPLANT (July 3, 2002)
  • K021418 — AART NASAL IMPLANT (July 2, 2002)
  • K021419 — AART MALAR IMPLANT (July 2, 2002)
  • K021417 — AART CHIN IMPLANT (July 2, 2002)

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)