FDA 510(k)

da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator

K-번호: K253556 · 2026-01-16

결정일2026-01-16

제품 코드NAY

자문 위원회GU

결정Substantially Equivalent

기기 요약

da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator 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 2026-01-16 under 510(k) number K253556. The device is classified under product code NAY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator?

da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K253556.

When did da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator receive FDA 510(k) clearance?

da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator received FDA 510(k) clearance on 2026-01-16, under 510(k) number K253556.

Who is the listed applicant for da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator?

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 Surgical System (SP1098); da Vinci E-200 Generator?

The FDA product code for da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator is NAY.

Intuitive Surgical, Inc.를 신청인으로 등재한 기타 기록

K261823da Vinci Surgical System, Model IS5000 K253702Intuitive Endoluminal Gastrointestinal System (IG1000)K261824da Vinci Surgical System, Model IS5000 K261249Universal Seal (5-12 mm)K253986da Vinci Force Feedback Instruments K253978Universal Seal (5-12 mm)

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