Cleared Traditional

Compass Steerable Needle

K221206 · Serpex Medical, Inc. · Anesthesiology

Aug 2022

Decision

121d

Days

Class 2

Risk

About This 510(k) Submission

K221206 is an FDA 510(k) clearance for the Compass Steerable Needle, a Bronchoscope Accessory (Class II — Special Controls, product code KTI), submitted by Serpex Medical, Inc. (Santa Clara, US). The FDA issued a Cleared decision on August 25, 2022, 121 days after receiving the submission on April 26, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K221206 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2022
Decision Date	August 25, 2022
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	KTI — Bronchoscope Accessory
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).