The following data is part of a premarket notification filed by Stryker with the FDA for Spy Laparoscope.
| Device ID | K221217 |
| 510k Number | K221217 |
| Device Name: | SPY Laparoscope |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker 5900 Optical Court San Jose, CA 95138 |
| Contact | Christie Samsa |
| Correspondent | Christie Samsa Stryker 5900 Optical Court San Jose, CA 95138 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-27 |
| Decision Date | 2022-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327575439 | K221217 | 000 |
| 07613327575231 | K221217 | 000 |
| 07613327575347 | K221217 | 000 |
| 07613327575354 | K221217 | 000 |
| 07613327575361 | K221217 | 000 |
| 07613327575378 | K221217 | 000 |
| 07613327575385 | K221217 | 000 |
| 07613327575392 | K221217 | 000 |
| 07613327575408 | K221217 | 000 |
| 07613327575415 | K221217 | 000 |
| 07613327575422 | K221217 | 000 |
| 07613327575224 | K221217 | 000 |