The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Monopolar Cautery Cord, Bipolar Cautery Cord.
| Device ID | K133167 |
| 510k Number | K133167 |
| Device Name: | MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER RD Sunnyvale, CA 94086 |
| Contact | Brandon Hansen |
| Correspondent | Brandon Hansen INTUITIVE SURGICAL, INC. 1266 KIFER RD Sunnyvale, CA 94086 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874112601 | K133167 | 000 |
| 00886874112595 | K133167 | 000 |