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FDA 510(k)

Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)

Número K: K252926 · 2026-03-26

RequerenteRestore Robotics
Data da decisão2026-03-26
Código do produtoQSM
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) is the device name listed in this FDA 510(k) record. The listed applicant is Restore Robotics. It received FDA 510(k) clearance on 2026-03-26 under 510(k) number K252926. The device is classified under product code QSM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)?

Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) is a medical device that received FDA 510(k) clearance on 2026-03-26. The listed applicant is Restore Robotics. The 510(k) number is K252926.

When did Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) receive FDA 510(k) clearance?

Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) received FDA 510(k) clearance on 2026-03-26, under 510(k) number K252926.

Who is the listed applicant for Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)?

The FDA 510(k) record lists Restore Robotics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)?

The FDA product code for Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) is QSM.

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