The following data is part of a premarket notification filed by Serpex Medical, Inc. with the FDA for Compass Steerable Needle.
| Device ID | K221206 |
| 510k Number | K221206 |
| Device Name: | Compass Steerable Needle |
| Classification | Bronchoscope Accessory |
| Applicant | Serpex Medical, Inc. 3350 Scott Blvd, Suite 37B Santa Clara, CA 95054 |
| Contact | Sasha Schrode |
| Correspondent | Laurie Lewandowski Honkanen Consulting, Inc. 738 Saddle Wood Drive Eagan, MN 55123 |
| Product Code | KTI |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-26 |
| Decision Date | 2022-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860009430228 | K221206 | 000 |