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.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00886874112083 | K122532 | 000 |
10886874112066 | K122532 | 000 |
00886874111956 | K122532 | 000 |
00886874111888 | K122532 | 000 |