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510(k) K022306

AART SILICONE TUBING by Aesthetic and Reconstructive Technologies, Inc. — Product Code KGZ

K022306 is an FDA 510(k) premarket notification submitted by Aesthetic and Reconstructive Technologies, Inc. for the device "AART SILICONE TUBING". The FDA issued a decision of Substantially Equivalent on October 10, 2002. The device falls under product code KGZ (Accessories, Catheter), a Class I device regulated under 21 CFR 878.4200. Aesthetic and Reconstructive Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2002
Date Received
July 16, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Aesthetic and Reconstructive Technologies, Inc.

  • K023678 — DIMISIL SCAR GEL (January 23, 2003)
  • K022511 — AART CALF IMPLANT (August 26, 2002)
  • K022223 — AART SILICONE SHEETING (August 8, 2002)
  • K021820 — AART SILICONE CARVING BLOCK (July 16, 2002)
  • K021839 — AART GLUTEAL IMPLANT (July 16, 2002)
  • K021337 — AART PECTORALIS IMPLANT (July 3, 2002)
  • K021419 — AART MALAR IMPLANT (July 2, 2002)
  • K021417 — AART CHIN IMPLANT (July 2, 2002)
  • K021418 — AART NASAL IMPLANT (July 2, 2002)

Other clearances for product code KGZ

  • K974295 — BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (February 10, 1998)
  • K973183 — WOUND DRAINAGE HOLDER (January 23, 1998)
  • K955433 — DURALASTIC SILICONE TUBING (January 26, 1996)
  • K942315 — NAVARRE PERCUTANEOUS ACCESS SET (July 8, 1994)
  • K896087 — PALESTRANT IRRIGATION AND DRAINAGE SET (November 3, 1989)
  • K895041 — OPTICAL CATHETER(TM) INTRODUCER SETS (October 16, 1989)
  • K893406 — DESERET PRN ADAPTER (June 22, 1989)
  • K873009 — CONCEPT SWITCHING STICK (August 17, 1987)
  • K870014 — HCI GENERAL PURPOSE CATHETER STYLET (February 6, 1987)
  • K864115 — TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU (November 7, 1986)

FDA data resources