SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE— 510(k) K120215

Clearance details

Applicant

Intuitive Surgical, Inc.

Product code

Code NAY

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2012-01-24

Decision date

2012-04-30

Decision

Unknown

Clearance type

Special

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

• K253702 — Intuitive Endoluminal Gastrointestinal System (IG1000)2026-08-07
• K261249 — Universal Seal (5-12 mm)2026-07-14
• K253978 — Universal Seal (5-12 mm)2026-02-24
• K251739 — da Vinci Surgical System (IS5000)2026-01-16
• K253556 — da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator2026-01-16

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-2751-2015 — Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428053-12, 428053-15. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.Class II·Terminated·Intuitive Surgical, Inc.·20150808
• Z-2754-2015 — Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058-12, 428058-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.Class II·Terminated·Intuitive Surgical, Inc.·20150808
• Z-2755-2015 — Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428059-12, 428059-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.Class II·Terminated·Intuitive Surgical, Inc.·20150808

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120215.