FDA.reportPublic FDA data

Recon Steerable Sheath

Primary DI
00860009430204
Brand
Recon Steerable Sheath
Company
SERPEX MEDICAL INC.
Model
RSS1000
Device description
The Recon Steerable Sheath is a sterile, single use transbronchial sheath with a unidirectional, steerable distal tip that provides access to the intrapulmonary regions.
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221302000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221302000Recon Steerable SheathSerpex Medical, Inc.2022-08-15EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009430204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009430204008600094302048600094302040860009430204

GMDN Terms#

Term, Definition table
TermDefinition
Bronchoscopic catheterA sterile, flexible, single lumen tube designed to be used as a conduit to the lung(s) for the delivery of another device (e.g., an emphysematous lung sealant) during a bronchoscopic procedure. It is typically made of synthetic materials that resist kinking (may be capable of bending 135 degrees or more without kinking) and is advanced through the working channel of a bronchoscope to the treatment site by the operator, typically a pulmonologist or thoracic surgeon. The distal tip may be marked with a band to facilitate visualization by the operator during the procedure. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118905661
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009430242Adapter SRA-2-01 SRA-2-01 2025-12-08
00860009430211Compass Steerable NeedleCSN10012025-12-08
00860009430235Adapter SRA-1-01 SRA-1-012025-12-08
10860009430249Adapter SRA-2-01 SRA-2-01 2025-12-08
00860009430228Compass Steerable NeedleCSN10012023-03-17

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Primary DI, Brand, Company table
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04719872715283MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
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04547410520545FUJIFILMFUJIFILM CORPORATIONEOQ2024-05-15
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10810068810780Monarch™ Laptop P70 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
10810068810797Monarch™ Laptop P17/P73 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
04048551446690N/AKarl Storz GmbH & Co. KGEOQ2023-08-14
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