SureForm 45, SureForm 45 Reloads— 510(k) K183224

Clearance details

Applicant

Intuitive Surgical

Product code

Code NAY

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2018-11-20

Decision date

2019-01-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sunnyvale, CA, US

• K261823 — da Vinci Surgical System, Model IS50002026-09-08
• K261824 — da Vinci Surgical System, Model IS50002026-07-31
• K260695 — da Vinci Firefly Imaging System2026-05-22
• K254192 — Senhance Ultrasonic System2026-05-12
• K253986 — da Vinci Force Feedback Instruments2026-03-11

• K241635 — da Vinci E-200 Electrosurgical Generator2024-08-05
• K241621 — Da Vinci Monopolar and Bipolar Adapters (378896)2024-08-02
• K240723 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)2024-05-24
• K231212 — da Vinci E-200 Electrosurgical Generator2023-06-21
• K223039 — da Vinci E-200 Electrosurgical Generator2022-11-28

Death

433

Injury

7,927

Malfunction

93,790

Other

19

Total

102,169

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0999-2022 — da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460Class II·Ongoing·Intuitive Surgical, Inc.·20220317

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183224.