Cleared Traditional

K243596 - da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243596 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Mar 2025
Decision
109d
Days
Class 2
Risk

K243596 is an FDA 510(k) clearance for the da Vinci SP SureForm 45 Staplers and Reloads (SP1098). Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Intuitive Surgical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 10, 2025 after a review of 109 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4740 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Intuitive Surgical, Inc. devices

Submission Details

510(k) Number K243596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2024
Decision Date March 10, 2025
Days to Decision 109 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 114d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAG Stapler, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4740
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAG Stapler, Surgical

All 41
Devices cleared under the same product code (GAG) and FDA review panel - the closest regulatory comparables to K243596.
AEON™ Endoscopic Powered Stapler
K251482 · Lexington Medical, Inc. · Jul 2025
Signia™ Circular Adapter (Standard Length) (SIGCIRSTND)
K240881 · Covidien (Part of Medtronic) · Nov 2024
ECHELON 3000 45mm Compact Stapler (ECH45C)
K241629 · Ethicon Endo-Surgery, LLC · Jul 2024
AEON Endoscopic Powered Stapler (Short/AEPH060)
K234039 · Lexington Medical, Inc. · May 2024
GIA™ Stapler with Tri-Staple™ Technology
K231934 · Covidien · Oct 2023
TA™ Stapler and Loading Unit with DST Series™ Technology
K231491 · Covidien · Aug 2023