Panels › Gastroenterology, Urology › Product code NAY · Class 2
System, Surgical, Computer Controlled Instrument
Regulation 876.1500
10510(k)s in 12 months (167 all time)
16recalls in 12 months (248 all time)
244recalls that name a 510(k)
Top companies in NAY
| Company | 510(k)s | Recalls |
|---|---|---|
| Intuitive Surgical | 148 | 246 |
| Transenterix, Inc. | 9 | 0 |
| Asensus Surgical | 6 | 1 |
| Aktormed GmbH | 2 | 0 |
| Computer Motion, Inc. | 2 | 0 |
| Olympus Corporation of the Americas | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Korean SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Relo Terminated |
NAY | K140553 |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Italian SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Rel Terminated |
NAY | K140553 |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Japanese SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Re Terminated |
NAY | K140553 |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Greek SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloa Terminated |
NAY | K140553 |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi German SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Relo Terminated |
NAY | K140553 |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Norwegian SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 R Terminated |
NAY | K140553 |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi French SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Relo Terminated |
NAY | K140553 |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Finnish SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Rel Terminated |
NAY | K140553 |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Dutch SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloa Terminated |
NAY | K140553 |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Czech SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloa Terminated |
NAY | K140553 |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Danish SRK.
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Rel Terminated |
NAY | K140553 |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi English SRK..
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 R Terminated |
NAY | K140553 |
| Oct 26, 2016 | Intuitive Surgical, Inc. da Vinci Xi" Surgical System, model number IS4000, A70_P5x with P5 Software;
General and Plastic Surgery:
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model I Terminated |
NAY | K131861 |
| Aug 26, 2016 | Intuitive Surgical, Inc. CURVED-TIP STAPLER 30,IS4000; Model number 470530;
General and Plastic Surgery:
The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the Terminated |
NAY | K152421 |
| Aug 26, 2016 | Intuitive Surgical, Inc. STAPLER 30,IS4000; Model number 470430;
General and Plastic Surgery:
The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci X Terminated |
NAY | K140553 |
| Aug 26, 2016 | Intuitive Surgical, Inc. STAPLER,IS4000; Model number 470298;
General and Plastic Surgery:
The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with t Terminated |
NAY | K140553 |
| Aug 5, 2016 | Intuitive Surgical, Inc. CURVED-TIP STAPLER 30,IS4000, model number 470530;
Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the d Terminated |
NAY | K152421 |
| Aug 5, 2016 | Intuitive Surgical, Inc. STAPLER 30, IS4000, model number 470430;
Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Terminated |
NAY | K152421 |
| Aug 5, 2016 | Intuitive Surgical, Inc. STAPLER 45, IS4000, model number 470298
Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with t Terminated |
NAY | K140553 |
| May 27, 2016 | Intuitive Surgical, Inc. SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provi Terminated |
NAY | K140553 |
| Mar 25, 2016 | Intuitive Surgical, Inc. EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software.
General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surg Terminated |
NAY | K131861 |
| Mar 16, 2016 | Intuitive Surgical, Inc. da Vinci S Surgical System (IS4000) user manual English and OUS.
Product Usage:
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assi Terminated |
NAY | K081137 K131861 |
| Mar 16, 2016 | Intuitive Surgical, Inc. da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory.
Product Usage:
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate Terminated |
NAY | K050369 |
| Feb 16, 2016 | Intuitive Surgical, Inc. da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The s Terminated |
NAY | K081137 K131861 |
| Jan 14, 2016 | Intuitive Surgical, Inc. 30 deg, 8mm Endoscope, IS4000:
Model numbers: 470027-34, 470027-40, 470027-41.
General and Plastic Surgery:
The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video Terminated |
NAY | K131861 |
| Jan 14, 2016 | Intuitive Surgical, Inc. 0 deg, 8mm Endoscope, IS4000:
Model numbers: 470026-34, 470026-40, 470026-41.
General and Plastic Surgery:
The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video i Terminated |
NAY | K131861 |
| Sep 17, 2015 | Intuitive Surgical, Inc. Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems;
Model numbers: 950156-01, 950156-02, 950156-03.
Product Usage: General and plastic surgery: The da Vinci Firefl Terminated |
NAY | K141077 |
| Sep 10, 2015 | Intuitive Surgical, Inc. Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428093-12, 428093-13.
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used wit Terminated |
NAY | K112208 K122532 +1 |
| Sep 10, 2015 | Intuitive Surgical, Inc. Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428088-12, 428088-13.
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the d Terminated |
NAY | K112208 K122532 +1 |
| Sep 10, 2015 | Intuitive Surgical, Inc. Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428080-04, 428080-05.
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with t Terminated |
NAY | K112208 K122532 +1 |
| Sep 10, 2015 | Intuitive Surgical, Inc. 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 V Terminated |
NAY | K120215 |
| Sep 10, 2015 | Intuitive Surgical, Inc. 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 Vinc Terminated |
NAY | K120215 |
| Sep 10, 2015 | Intuitive Surgical, Inc. Needle Driver; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428056-12, 428056-13.
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Terminated |
NAY | K112208 K122532 +1 |
| Sep 10, 2015 | Intuitive Surgical, Inc. Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428055-12, 428055-13.
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vin Terminated |
NAY | K112208 K122532 +1 |
| Sep 10, 2015 | Intuitive Surgical, Inc. 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 Terminated |
NAY | K120215 K130726 |
| Sep 10, 2015 | Intuitive Surgical, Inc. Maryland Dissector; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428050-12, 428050-13 and 428050-14;
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used Terminated |
NAY | K112208 K122532 +1 |
| Sep 3, 2015 | Intuitive Surgical, Inc. da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 :
General and Plastic surgery:
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Mode Terminated |
NAY | K131861 |
| Jul 1, 2015 | Intuitive Surgical, Inc. INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System.
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assi Terminated |
NAY | K131861 |
| Jun 17, 2015 | Intuitive Surgical, Inc. Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems.
Intended for endoscopic manipulation of tissue, including grasping. Terminated |
NAY | K050369 |
| Mar 20, 2015 | Intuitive Surgical, Inc. da Vinci Xi Surgical System, IS4000;
ASSY,USM,IS4000,
Material number: 380647-20 and 380647-22
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is i Terminated |
NAY | K131861 |
| Mar 20, 2015 | Intuitive Surgical, Inc. da Vinci Xi Surgical System, IS4000;
ASSY,DISTAL SUJ,OUTER,IS4000,
Material number: 380663-20 and 380663-21.
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Mod Terminated |
NAY | K131861 |
| Mar 20, 2015 | Intuitive Surgical, Inc. da Vinci Xi Surgical System, IS4000;
Assy, Distal SUJ, Inner, IS4000
Material number: 380662-20 and 380662-21.
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, M Terminated |
NAY | K131861 |
| Feb 27, 2015 | Intuitive Surgical, Inc. Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000);
Part number 420187-05.
The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used wit Terminated |
NAY | K060391 K080291 |
| Feb 24, 2015 | Intuitive Surgical, Inc. EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000.
The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the Terminated |
NAY | K140189 |
| Feb 24, 2015 | Intuitive Surgical, Inc. EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000
The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Terminated |
NAY | K110639 |
| Feb 13, 2015 | Intuitive Surgical, Inc. HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000.
Intended for soft tissue incisions when bleeding control and minima Terminated |
NAY | K093217 |
| Feb 13, 2015 | Intuitive Surgical, Inc. HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System.
Intended for soft tissue incisions when bleeding control and minimal thermal injury a Terminated |
NAY | K093217 |
| Feb 3, 2015 | Intuitive Surgical, Inc. da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System.
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | K123463 |
| Jan 7, 2015 | Intuitive Surgical, Inc. IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000.
Product number 371683-05/Model Number VS3000
The Intuitive Surgical Endoscopic Instrument Control Syste Terminated |
NAY | K081137 |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM, TIP-UP FENESTRATED GRASPER;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | K131861 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.