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510(k) K030879

VERITAS COLLAGEN MATRIX by Synovis Surgical Innovations — Product Code OXE

K030879 is an FDA 510(k) premarket notification submitted by Synovis Surgical Innovations for the device "VERITAS COLLAGEN MATRIX". The FDA issued a decision of Substantially Equivalent on April 24, 2003. The device falls under product code OXE (Mesh, Surgical, Collagen, Staple Line Reinforcement), a Class II device regulated under 21 CFR 878.3300. Synovis Surgical Innovations has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2003
Date Received
March 20, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Collagen, Staple Line Reinforcement
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.

Other clearances by Synovis Surgical Innovations

  • K122306 — SYNOVIS COLLAGEN MATRIX (TBD) (March 8, 2013)
  • K083039 — VERITAS COLLAGEN MATRIX (DRY) (November 26, 2008)
  • K062915 — VERITAS COLLAGEN MATRIX (December 6, 2006)
  • K041669 — VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD (October 27, 2004)
  • K040415 — PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PE (April 14, 2004)
  • K040119 — PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE L (March 17, 2004)
  • K040001 — STEERABLE STYLET (March 9, 2004)

Other clearances for product code OXE

  • K170945 — Biodesign Staple Line Reinforcement (April 28, 2017)
  • K153364 — Kerecis SecureMesh (August 19, 2016)
  • K022044 — SURGISIS STAPLE LINE REINFORCEMENT (August 23, 2002)

FDA data resources