The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Intuitive Surgical Bipolar Forceps.
Device ID | K012833 |
510k Number | K012833 |
Device Name: | INTUITIVE SURGICAL BIPOLAR FORCEPS |
Classification | System, Surgical, Computer Controlled Instrument |
Applicant | INTUITIVE SURGICAL, INC. 1340 WEST MIDDLEFIELD RD. Mountain View, CA 94043 |
Contact | Michael Yramategui |
Correspondent | Michael Yramategui INTUITIVE SURGICAL, INC. 1340 WEST MIDDLEFIELD RD. Mountain View, CA 94043 |
Product Code | NAY |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-23 |
Decision Date | 2001-11-16 |
Summary: | summary |