DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES

System, Surgical, Computer Controlled Instrument

INTUITIVE SURGICAL, INC.

The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci Single-site Instruments And Accessories.

Pre-market Notification Details

• Device ID: K122532
• 510k Number: K122532
• Device Name: DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES
• Classification: System, Surgical, Computer Controlled Instrument
• Applicant: INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale, CA 94086 -5206
• Contact: Melissa S Gonzalez
• Correspondent: Melissa S Gonzalez; INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale, CA 94086 -5206
• Product Code: NAY
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Se - With Limitations (SESU)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-08-20
• Decision Date: 2013-07-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00886874112083	K122532	000
10886874112066	K122532	000
00886874111956	K122532	000
00886874111888	K122532	000