Atlas FDA

DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES

FDA 510(k) clearance K131861 · decided 2014-03-28

Clearance details

K-number
K131861
Device name
DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
Applicant
Intuitive Surgical, Inc.
Decision
Substantially Equivalent
Date received
2013-06-24
Decision date
2014-03-28
Days to decision
277 days
Clearance type
Traditional
Product code
NAY
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Sunnyvale, CA, US
Third-party review
No
Expedited review
No

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da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator (K253556)Intuitive Surgical, Inc.2026-01-16
da Vinci SP Surgical System (SP1098) (K252675)Intuitive Surgical, Inc.2025-12-15
da Vinci SP Surgical System (SP1098) (K252069)Intuitive Surgical, Inc.2025-12-02
da Vinci SP Surgical System (SP1098) (K251426)Intuitive Surgical, Inc.2025-10-03
da Vinci SP Surgical System (SP1098) (K251817)Intuitive Surgical, Inc.2025-09-10
da Vinci Surgical System (IS5000) (K251227)Intuitive Surgical, Inc.2025-09-08
da Vinci SP Surgical System (SP1098) (K251324)Intuitive Surgical, Inc.2025-08-29

Recalls involving this device

RecordFirmDate
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/ recall (Z-2046-2026)Intuitive Surgical, Inc.2026-05-01
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical S recall (Z-1232-2026)Intuitive Surgical, Inc.2026-02-02
8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems recall (Z-0923-2025)Intuitive Surgical, Inc.2025-01-16
8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/ recall (Z-0924-2025)Intuitive Surgical, Inc.2025-01-16
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179 recall (Z-0847-2025)Intuitive Surgical, Inc.2025-01-10
8MM, POTTS SCISSORS, IS4000 REF 470001 recall (Z-0848-2025)Intuitive Surgical, Inc.2025-01-10
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 recall (Z-0849-2025)Intuitive Surgical, Inc.2025-01-10
8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 REF 470033 recall (Z-0851-2025)Intuitive Surgical, Inc.2025-01-10
8MM,PROGRASP FORCEPS,IS4000 REF 470093 recall (Z-0854-2025)Intuitive Surgical, Inc.2025-01-10
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 470171 recall (Z-0855-2025)Intuitive Surgical, Inc.2025-01-10
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 470172 recall (Z-0856-2025)Intuitive Surgical, Inc.2025-01-10
8MM,RESANO FORCEPS,IS4000 REF 470181 recall (Z-0857-2025)Intuitive Surgical, Inc.2025-01-10
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 470205 recall (Z-0859-2025)Intuitive Surgical, Inc.2025-01-10
8MM,TENACULUM FORCEPS,IS4000 REF 470207 recall (Z-0860-2025)Intuitive Surgical, Inc.2025-01-10
8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000 REF 470230 recall (Z-0861-2025)Intuitive Surgical, Inc.2025-01-10
8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000 REF 470246 recall (Z-0862-2025)Intuitive Surgical, Inc.2025-01-10
8MM,DUAL BLADE RETRACTOR,IS4000 REF 470249 recall (Z-0863-2025)Intuitive Surgical, Inc.2025-01-10
8MM,MEGA SUTURECUT ND,IS4000 REF 470309 recall (Z-0865-2025)Intuitive Surgical, Inc.2025-01-10
8MM,SMALL GRASPING RETRACTOR,IS4000 REF 470318 recall (Z-0866-2025)Intuitive Surgical, Inc.2025-01-10
8MM,MEDIUM-LARGE CLIP APPLIER,IS4000 REF 470327 recall (Z-0867-2025)Intuitive Surgical, Inc.2025-01-10
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 470344 recall (Z-0868-2025)Intuitive Surgical, Inc.2025-01-10
8MM,TIP-UP FENESTRATED GRASPER,IS4000 REF 470347 recall (Z-0869-2025)Intuitive Surgical, Inc.2025-01-10
8MM,LONG TIP FORCEPS,IS4000 REF 471048 recall (Z-0872-2025)Intuitive Surgical, Inc.2025-01-10
8MM,PROGRASP FORCEPS,IS4000 REF 471093 recall (Z-0874-2025)Intuitive Surgical, Inc.2025-01-10
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171 recall (Z-0875-2025)Intuitive Surgical, Inc.2025-01-10
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172 recall (Z-0876-2025)Intuitive Surgical, Inc.2025-01-10
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 recall (Z-0878-2025)Intuitive Surgical, Inc.2025-01-10
8MM,MEGA SUTURECUT ND,IS4000 REF 471309 recall (Z-0880-2025)Intuitive Surgical, Inc.2025-01-10
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 recall (Z-0881-2025)Intuitive Surgical, Inc.2025-01-10
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12 recall (Z-2059-2023)Intuitive Surgical, Inc.2023-06-30
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200 recall (Z-1293-2023)Intuitive Surgical, Inc.2023-03-28
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgi recall (Z-1262-2023)Intuitive Surgical, Inc.2023-03-16
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Co recall (Z-0133-2023)Intuitive Surgical, Inc.2022-10-25
da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is des recall (Z-2630-2017)Intuitive Surgical, Inc.2017-06-06
da Vinci Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and P recall (Z-0315-2017)Intuitive Surgical, Inc.2016-10-26
0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and recall (Z-0652-2016)Intuitive Surgical, Inc.2016-01-14
30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and recall (Z-0653-2016)Intuitive Surgical, Inc.2016-01-14
da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and recall (Z-2734-2015)Intuitive Surgical, Inc.2015-09-03
INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuit recall (Z-1949-2015)Intuitive Surgical, Inc.2015-07-01
da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 3806 recall (Z-1302-2015)Intuitive Surgical, Inc.2015-03-20
da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663 recall (Z-1303-2015)Intuitive Surgical, Inc.2015-03-20
da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 38064 recall (Z-1304-2015)Intuitive Surgical, Inc.2015-03-20
8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endos recall (Z-0427-2015)Intuitive Surgical, Inc.2014-11-25
8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive Surgical recall (Z-0428-2015)Intuitive Surgical, Inc.2014-11-25
8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive S recall (Z-0429-2015)Intuitive Surgical, Inc.2014-11-25
8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical End recall (Z-0430-2015)Intuitive Surgical, Inc.2014-11-25
8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgica recall (Z-0431-2015)Intuitive Surgical, Inc.2014-11-25
8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical End recall (Z-0432-2015)Intuitive Surgical, Inc.2014-11-25
8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surg recall (Z-0433-2015)Intuitive Surgical, Inc.2014-11-25
8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Sur recall (Z-0434-2015)Intuitive Surgical, Inc.2014-11-25