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510(k) K221487

NEOVEIL Staple Line Reinforcement by Gunze Limited — Product Code OXC

K221487 is an FDA 510(k) premarket notification submitted by Gunze Limited for the device "NEOVEIL Staple Line Reinforcement". The FDA issued a decision of Substantially Equivalent on August 26, 2022. 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
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)

FDA data resources