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510(k) K231603

Standard Staple-Line Reinforcement (SSLR23) by Standard Bariatrics, Inc. — Product Code OXC

K231603 is an FDA 510(k) premarket notification submitted by Standard Bariatrics, Inc. for the device "Standard Staple-Line Reinforcement (SSLR23)". The FDA issued a decision of Substantially Equivalent on October 6, 2023. The device falls under product code OXC (Mesh, Surgical, Absorbable, Staple Line Reinforcement), a Class II device regulated under 21 CFR 878.3300. Standard Bariatrics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2023
Date Received
June 1, 2023
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 Standard Bariatrics, Inc.

  • K222085 — Standard Tapered Bougie, 38 Fr. (October 31, 2022)
  • K212728 — Standard Bougie, 38 Fr. and Hand Pump (September 23, 2021)
  • K210437 — Standard Bougie, 38 Fr. (June 29, 2021)
  • K210278 — Titan SGS (April 28, 2021)
  • K200517 — Standard Trocar (April 9, 2020)
  • K191885 — Standard Bougie (April 8, 2020)
  • K190788 — Disposable Standard Clamp (April 18, 2019)
  • K181608 — Disposable Standard Clamp (September 27, 2018)
  • K170379 — Disposable Standard Clamp (July 19, 2017)
  • K161720 — Standard Clamp (October 24, 2016)

Other clearances for product code OXC

  • K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) (January 9, 2026)
  • 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)
  • K130997 — NEOVEIL (November 15, 2013)
  • K131658 — GORE SEAMGUARD REINFORCEMENT (September 6, 2013)

FDA data resources