Home / 510(k) Clearances / K053066

510(k) K053066

SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH by Genzyme Corporation — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2005
Date Received
November 1, 2005
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 Genzyme Corporation

  • K102242 — OSOM C. DIFFICILE TOXIN A/B TEST (December 21, 2010)
  • K092633 — OSOM INFLUENZA A&B TEST , MODEL PN190 (September 25, 2009)
  • K080662 — GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR (May 15, 2008)
  • K063739 — SEPRAMESH, MODEL 5959-1214 (January 17, 2007)
  • K043035 — SEPRAGEL ENT BIORESORBABLE PACKING/STENT (July 11, 2005)

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)