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510(k) K954382

PROLASTIC SHEETING by Pillar Surgical — Product Code MIB

K954382 is an FDA 510(k) premarket notification submitted by Pillar Surgical for the device "PROLASTIC SHEETING". The FDA issued a decision of Substantially Equivalent on November 29, 1995. The device falls under product code MIB (Elastomer, Silicone Block), a Class II device regulated under 21 CFR 874.3620. Pillar Surgical has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1995
Date Received
September 19, 1995
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 Pillar Surgical

  • K002633 — SILMAX PECTORAL IMPLANT (November 21, 2000)
  • K002629 — SILMAX CONTOUR CARVING BLOCK IMPLANT (November 20, 2000)
  • K992239 — PILLAR CHIN IMPLANT (November 22, 1999)
  • K992242 — PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS (November 22, 1999)
  • K992240 — PILLAR MALAR IMPLANT (November 22, 1999)
  • K991970 — SCAREASE SHEETS & SCAREASE GEL (October 25, 1999)

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)

FDA data resources