The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Universal Cannula Seal (5-12 Mm).
| Device ID | K181395 |
| 510k Number | K181395 |
| Device Name: | Universal Cannula Seal (5-12 Mm) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Cheryl Wu |
| Correspondent | Cheryl Wu Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-29 |
| Decision Date | 2018-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30886874116402 | K181395 | 000 |