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510(k) K221487

NEOVEIL Staple Line Reinforcement by Gunze Limited — Product Code OXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2022
Date Received
May 23, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Absorbable, 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 Gunze Limited

  • K213498 — PELNAC Meshed Bilayer Wound Matrix (July 14, 2022)
  • K213573 — PELNAC Wound Matrix (February 9, 2022)
  • K191992 — PELNAC Bilayer Wound Matrix (April 29, 2020)
  • K130997 — NEOVEIL (November 15, 2013)

Other clearances for product code OXC

  • K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) (January 9, 2026)
  • K231603 — Standard Staple-Line Reinforcement (SSLR23) (October 6, 2023)
  • K221343 — ECHELON ENDOPATH Staple Line Reinforcement (September 16, 2022)
  • K190937 — Echelon Endopath Staple Line Reinforcement (October 14, 2019)
  • K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (August 17, 2018)
  • K150551 — GORE SEAMGUARD Reinforcement (March 30, 2015)
  • K130997 — NEOVEIL (November 15, 2013)
  • K131658 — GORE SEAMGUARD REINFORCEMENT (September 6, 2013)