Home / 510(k) Clearances / K003323

510(k) K003323

COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 by Davol, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2001
Date Received
October 24, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by Davol, Inc.

  • K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped (June 12, 2025)
  • K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (April 9, 2025)
  • K031213 — AQUASENS FLUID MONITORING SYSTEM (April 30, 2003)
  • K030307 — DAVOL ARTHROVENT OUTFLOW TUBING (February 13, 2003)
  • K003790 — DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, (December 22, 2000)
  • K931899 — DAVOL ATS (November 15, 1994)
  • K941334 — DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE (June 14, 1994)
  • K921405 — DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP (March 25, 1994)
  • K935503 — DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET (March 7, 1994)
  • K926479 — BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM (March 1, 1994)

Other clearances for product code FTL

  • K253125 — Parietene™ Flat Sheet Mesh (October 24, 2025)
  • K251955 — Onflex™ Mesh (July 24, 2025)
  • K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped (June 12, 2025)
  • K250869 — Parietene™ Macroporous Mesh (PPM5050 ) (April 23, 2025)
  • K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (April 9, 2025)
  • K243315 — ProGrip™ Self-Gripping Polypropylene Mesh (January 17, 2025)
  • K241250 — 3DMax Light Mesh (June 14, 2024)
  • K232373 — Progrip™ Self-Gripping Polypropylene Mesh (January 18, 2024)
  • K233402 — Bard 3DMax Mesh (November 1, 2023)
  • K232924 — T-Line® Hernia Mesh (October 18, 2023)