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FDA 510(k)

da Vinci SP SureForm 45 Staplers and Reloads (SP1098)

K-Number: K243596 · 2025-03-10

ApplicantIntuitive Surgical, Inc.
Decision Date2025-03-10
Product CodeGAG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

da Vinci SP SureForm 45 Staplers and Reloads (SP1098) is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2025-03-10 under 510(k) number K243596. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the da Vinci SP SureForm 45 Staplers and Reloads (SP1098)?

da Vinci SP SureForm 45 Staplers and Reloads (SP1098) is a medical device that received FDA 510(k) clearance on 2025-03-10. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K243596.

When did da Vinci SP SureForm 45 Staplers and Reloads (SP1098) receive FDA 510(k) clearance?

da Vinci SP SureForm 45 Staplers and Reloads (SP1098) received FDA 510(k) clearance on 2025-03-10, under 510(k) number K243596.

Who is the listed applicant for da Vinci SP SureForm 45 Staplers and Reloads (SP1098)?

The FDA 510(k) record lists Intuitive Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for da Vinci SP SureForm 45 Staplers and Reloads (SP1098)?

The FDA product code for da Vinci SP SureForm 45 Staplers and Reloads (SP1098) is GAG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04403022da Vinci SP® Investigational Device Exemption Study in Colorectal ProceduresACTIVE_NOT_RECRUITINGNCT05867927GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological IndicationsRECRUITINGNCT06084208Assessment of Diagnostic Yield Using a Robotic Navigational Bronchoscopy System With CBCTCOMPLETEDNCT06308120A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENBACTIVE_NOT_RECRUITINGNCT06923774European Real-World Registry for Use of the Ion Endoluminal SystemRECRUITINGNCT07655505Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve RepairENROLLING_BY_INVITATION

Other records listing Intuitive Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253702Intuitive Endoluminal Gastrointestinal System (IG1000)K261824da Vinci Surgical System, Model IS5000K261249Universal Seal (5-12 mm)K260695da Vinci Firefly Imaging SystemK253986da Vinci Force Feedback InstrumentsK253978Universal Seal (5-12 mm)

View all 124 devices →

Related Devices (Code: GAG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)Covidien, LLCK251482AEON™ Endoscopic Powered StaplerLexington Medical, Inc.K240881Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)Covidien (Part of Medtronic)K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)Ethicon Endo-Surgery, LLCK234039AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)Lexington Medical, Inc.K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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