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 |