The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for 8 Mm Sureform 30 Curved-tip Stapler, 8 Mm Sureform 30 Stapler, Sureform 30 Reloads.
| Device ID | K211997 |
| 510k Number | K211997 |
| Device Name: | 8 Mm SureForm 30 Curved-Tip Stapler, 8 Mm SureForm 30 Stapler, SureForm 30 Reloads |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Amrit Jaggi |
| Correspondent | Amrit Jaggi 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 | 2021-06-28 |
| Decision Date | 2021-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886874121938 | K211997 | 000 |
| 10886874121921 | K211997 | 000 |
| 10886874121914 | K211997 | 000 |
| 10886874121723 | K211997 | 000 |