Compass Steerable Needle— 510(k) K221206

Substantially Equivalent

Serpex Medical, Inc.

FDA 510(k) clearance K221206 for Compass Steerable Needle, Substantially Equivalent on 2022-08-25. Applicant: Serpex Medical, Inc..

Clearance details

Applicant: Serpex Medical, Inc.
Product code: Code KTI
Advisory panel: Ear, Nose, Throat
Date received: 2022-04-26
Decision date: 2022-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTI

product code KTI

Malfunction: 642
Total: 642

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.