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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 a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2025-03-10 under approval 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. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K243596.

When was da Vinci SP SureForm 45 Staplers and Reloads (SP1098) approved by the FDA?

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

What company makes da Vinci SP SureForm 45 Staplers and Reloads (SP1098)?

da Vinci SP SureForm 45 Staplers and Reloads (SP1098) is manufactured by Intuitive Surgical, Inc..

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

NCT05672368 The da Vinci Single Port Robotic System for Use in Abdominal and Pelvic Surgical Procedures RECRUITING

Other Devices by Intuitive Surgical, Inc.

K162411da Vinci Xi 12 – 8 mm Reducer K153276da Vinci Xi Surgical System K161271da Vinci Xi Surgical System K152578da Vinci Surgical System, Model IS4000 K152448da Vinci Single-Site Instrument and Accessories K152421IS4000 Stapler 30 Instrument and Stapler 30 Reloads

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Related Devices (Code: GAG)

K213633ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerEthicon Endo-Surgery, LLC K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien K232126EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler AnvilCovidien K221629Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)Covidien K240881Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)Covidien (Part of Medtronic)

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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