510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243596Substantially Equivalent

da Vinci SP SureForm 45 Staplers and Reloads (SP1098)

Intuitive Surgical, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243596 is the FDA 510(k) clearance record for da Vinci SP SureForm 45 Staplers and Reloads (SP1098), a class II device, cleared for Intuitive Surgical, Inc. on under FDA product code GAG (Stapler, Surgical). FDA's definition for product code GAG reads: "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". FDA records list 196 510(k) clearances for Intuitive Surgical, Inc., from to . As of , FDA records show no recalls naming K243596.

Clearance record

Decision date
Received
(109 days to decision)
Product code
GAG Stapler, Surgical
Regulation
21 CFR 878.4740
Device class
Class II
Review panel
General Hospital
Applicant
Intuitive Surgical, Inc. 1266 Kifer Rd., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAG

Trailing 12 months
1 clearance under product code GAG in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GAG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260