The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for 12 Mm Endoscopes And Accessories.
| Device ID | K142683 |
| 510k Number | K142683 |
| Device Name: | 12 Mm Endoscopes And Accessories |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 -5206 |
| Contact | Crystal Ong |
| Correspondent | Crystal Ong INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 -5206 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-19 |
| Decision Date | 2014-12-10 |
| Summary: | summary |