Recon Steerable Sheath

GUDID 00860009430204

The Recon Steerable Sheath is a sterile, single use transbronchial sheath with a unidirectional, steerable distal tip that provides access to the intrapulmonary regions.

SERPEX MEDICAL INC.

Bronchoscopic catheter

• Primary Device ID: 00860009430204
• NIH Device Record Key: 8d80cfd1-4dbc-41e0-8b20-52099a397af2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Recon Steerable Sheath
• Version Model Number: RSS1000
• Company DUNS: 118905661
• Company Name: SERPEX MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009430204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221302

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-16
• Device Publish Date: 2025-12-08

Devices Manufactured by SERPEX MEDICAL INC.

• 00860009430204 - Recon Steerable Sheath: 2025-12-16The Recon Steerable Sheath is a sterile, single use transbronchial sheath with a unidirectional, steerable distal tip that provides access to the intrapulmonary regions.
• 00860009430204 - Recon Steerable Sheath: 2025-12-16 The Recon Steerable Sheath is a sterile, single use transbronchial sheath with a unidirectional, steerable distal tip that provi
• 00860009430211 - Compass Steerable Needle: 2025-12-16 The Compass Steerable Needle (CSN) is sterile, single use, 22-gauge transbronchial needle with a unidirectional, steerable dista
• 00860009430235 - Adapter SRA-1-01: 2025-12-16 Adapter SRA-1-01 connects the Model CSN1002 to the Ion™ Endoluminal System
• 10860009430249 - Adapter SRA-2-01: 2025-12-16 Adapter SRA-2-01 connects the Model CSN1002 to the Monarch™ Platform or Galaxy System™
• 00860009430228 - Compass Steerable Needle: 2023-03-27 Transbronchial Biopsy Needle