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510(k) K251557

Bard® Mesh; Bard® Mesh Pre-Shaped by Davol, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2025
Date Received
May 21, 2025
Clearance Type
Special
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.

  • 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)
  • K003323 — COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 (January 22, 2001)
  • 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)
  • 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)
  • K230671 — Pitch PaSoft Tissue Reinforcement Device (May 31, 2023)