The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/n 400170.
| Device ID | K040948 | 
| 510k Number | K040948 | 
| Device Name: | INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170 | 
| Classification | System, Surgical, Computer Controlled Instrument | 
| Applicant | INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 | 
| Contact | Michael H Yramategui | 
| Correspondent | Michael H Yramategui INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 | 
| Product Code | NAY | 
| CFR Regulation Number | 876.1500 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Special | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2004-04-12 | 
| Decision Date | 2004-05-05 | 
| Summary: | summary | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| 00886874111451 | K040948 | 000 |