Identifiers
- 510(k) Number
- K221302 FDA 510(k)
- FDA Product Code
- EOQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4680 FDA 510(k)
- Regulation Number
- 874.4680 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Recon Steerable Sheath is a bronchoscope accessory designed for use with flexible or rigid bronchoscopes. It is classified as a Class II medical device under product code EOQ.
The device received FDA 510(k) clearance (K221302) on August 15, 2022, and is substantially equivalent to a predicate device. It is manufactured by Serpex Medical, Inc. and is intended for use in ear, nose, and throat procedures as indicated by the advisory committee classification.
Frequently asked questions
What is the Recon Steerable Sheath used for?
The Recon Steerable Sheath is a bronchoscope accessory designed for use with flexible or rigid bronchoscopes in ear, nose, and throat procedures, as indicated by its advisory committee classification for ENT applications.
How is the Recon Steerable Sheath supplied and is it reusable?
The device data does not specify whether the Recon Steerable Sheath is supplied sterile or non-sterile, or whether it is intended for single-use or reuse; therefore, no conclusion can be drawn about its supply state or reusability from the provided information.
What regulatory pathway was used for the Recon Steerable Sheath?
The Recon Steerable Sheath received FDA 510(k) clearance under the traditional pathway, with clearance granted on August 15, 2022, under K221302, and was found substantially equivalent to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Serpex Medical, Inc. ℅ Laurie Lewandowski Vice President Honkanen ..., Recon Steerable Sheath (K221302) - FDA 510 (k), Recon Steerable Sheath (K221302) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221302 | Class II | Active |
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Manufacturer
- Manufacturer
- Serpex Medical, Inc.
Sources (1)
- FDA 510(k) K221302 24 fields · synced Sep 22, 2026