FDA 510(k)

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

Номер K: K252926 · 2026-03-26

Дата решения2026-03-26

Код продуктаQSM

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: QSM)

K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix K250539Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix K2426108мм Монополярные Кривые Ножницы (470179)Iconocare Health K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix

Официальный источник

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