The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Endowrist Vessel Sealer.
Device ID | K140189 |
510k Number | K140189 |
Device Name: | ENDOWRIST VESSEL SEALER |
Classification | System, Surgical, Computer Controlled Instrument |
Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 |
Contact | Nadine Nasr |
Correspondent | Nadine Nasr INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 |
Product Code | NAY |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-24 |
Decision Date | 2014-06-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10886874112745 | K140189 | 000 |