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510(k) K002633

SILMAX PECTORAL IMPLANT by Pillar Surgical, Inc. — Product Code MIC

K002633 is an FDA 510(k) premarket notification submitted by Pillar Surgical, Inc. for the device "SILMAX PECTORAL IMPLANT". The FDA issued a decision of Substantially Equivalent on November 21, 2000. The device falls under product code MIC (Implant, Muscle, Pectoralis), a Class II device regulated under 21 CFR 874.3620. Pillar Surgical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2000
Date Received
August 23, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Muscle, Pectoralis
Device Class
Class II
Regulation Number
874.3620
Review Panel
SU
Submission Type

Other clearances by Pillar Surgical, Inc.

  • 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)
  • K954382 — PROLASTIC SHEETING (November 29, 1995)

Other clearances for product code MIC

  • K021337 — AART PECTORALIS IMPLANT (July 3, 2002)
  • K983043 — SEARE BIOMEDICAL SILICONE BLOCK (September 30, 1998)
  • K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANT (September 30, 1998)
  • K973729 — POWERFLEX PEC IMPLANT (December 24, 1997)
  • K961072 — PEC IMPLANT (April 19, 1996)
  • K944163 — SPECTRUM DISIGNS PECTORAL IMPLANT (November 7, 1994)
  • K913768 — PEC IMPLANT (February 3, 1992)

FDA data resources