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510(k) K130997

NEOVEIL by Gunze Limited — Product Code OXC

K130997 is an FDA 510(k) premarket notification submitted by Gunze Limited for the device "NEOVEIL". The FDA issued a decision of Substantially Equivalent on November 15, 2013. The device falls under product code OXC (Mesh, Surgical, Absorbable, Staple Line Reinforcement), a Class II device regulated under 21 CFR 878.3300. Gunze Limited has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2013
Date Received
April 10, 2013
Clearance Type
Traditional
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

  • K221487 — NEOVEIL Staple Line Reinforcement (August 26, 2022)
  • K213498 — PELNAC Meshed Bilayer Wound Matrix (July 14, 2022)
  • K213573 — PELNAC Wound Matrix (February 9, 2022)
  • K191992 — PELNAC Bilayer Wound Matrix (April 29, 2020)

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)
  • K221487 — NEOVEIL Staple Line Reinforcement (August 26, 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)
  • K131658 — GORE SEAMGUARD REINFORCEMENT (September 6, 2013)

FDA data resources