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510(k) K013987

REPROCESSED DISPOSABLE TROCARS by Adven Medical — Product Code KBG

K013987 is an FDA 510(k) premarket notification submitted by Adven Medical for the device "REPROCESSED DISPOSABLE TROCARS". The FDA issued a decision of Substantially Equivalent on March 1, 2002. The device falls under product code KBG (Trocar, Sinus), a Class I device regulated under 21 CFR 874.4420. Adven Medical has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2002
Date Received
December 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar, Sinus
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Adven Medical

  • K021528 — REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP (August 21, 2002)
  • K012675 — REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS (February 12, 2002)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (February 4, 2002)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (February 4, 2002)
  • K940501 — RE-SHARPENABLE SAW BLADES (June 28, 1994)

Other clearances for product code KBG

  • K033591 — REPROCESSED TROCARS (June 3, 2005)
  • K844186 — CONTINENT STOMA SYSTEM & ACCESSORIES (January 15, 1985)

FDA data resources