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510(k) K243596

da Vinci SP SureForm 45 Staplers and Reloads (SP1098) by Intuitive Surgical, Inc. — Product Code GAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2025
Date Received
November 21, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stapler, Surgical
Device Class
Class II
Regulation Number
878.4740
Review Panel
SU
Submission Type

A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.

Other clearances by Intuitive Surgical, Inc.

  • K253986 — da Vinci Force Feedback Instruments (March 11, 2026)
  • K253978 — Universal Seal (5-12 mm) (February 24, 2026)
  • K251739 — da Vinci Surgical System (IS5000) (January 16, 2026)
  • K253556 — da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator (January 16, 2026)
  • K251763 — IRISeg (December 16, 2025)
  • K252675 — da Vinci SP Surgical System (SP1098) (December 15, 2025)
  • K252069 — da Vinci SP Surgical System (SP1098) (December 2, 2025)
  • K251426 — da Vinci SP Surgical System (SP1098) (October 3, 2025)
  • K252045 — Ion Endoluminal System (IF1000) (September 23, 2025)
  • K251817 — da Vinci SP Surgical System (SP1098) (September 10, 2025)

Other clearances for product code GAG

  • K251482 — AEON™ Endoscopic Powered Stapler (July 11, 2025)
  • K240881 — Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapte (November 1, 2024)
  • K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (July 3, 2024)
  • K234039 — AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (May 7, 2024)
  • K231934 — GIA™ Stapler with Tri-Staple™ Technology (October 27, 2023)
  • K232126 — EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular S (August 16, 2023)
  • K231491 — TA™ Stapler and Loading Unit with DST Series™ Technology (August 16, 2023)
  • K221629 — Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) (February 22, 2023)
  • K213633 — ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler (April 8, 2022)
  • K970079 — PROXIMATE DISPOSABLE SKIN STAPLER (March 11, 1997)