Compass Steerable Needle

Basic Information

• Brand Name: Compass Steerable Needle
• Primary DI: 00860009430211
• Version / Model: CSN1001
• Company Name: SERPEX MEDICAL INC.
• Labeler DUNS: 118905661
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-08
• Public Version: 1
• Public Version Date: 2025-12-16
• Public Version Status: New
• Public Device Record Key: 4d8d778a-582a-4dfb-ba4d-2a7e726e8ce5

Device Description

The Compass Steerable Needle (CSN) is sterile, single use, 22-gauge transbronchial needle with a unidirectional, steerable distal tip for the acquisition of tissue from the intrapulmonary regions.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTI	Bronchoscope Accessory	Ear, Nose, Throat	874.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35886	Body aspiration needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009430211	GS1

Premarket Submissions

Submission Number	Supplement Number
K252874	000