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 |