FDA.reportPublic FDA data

EasyPath RF Introducer Sheath

Primary DI
00856571007265
Brand
EasyPath RF Introducer Sheath
Company
BRONCUS MEDICAL INC.
Model
10011
Published
2026-04-23
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
K200702000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200702000EasyPath RF Introducer SheathBroncus Medical, Inc.2021-01-14EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856571007265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856571007265008565710072658565710072650856571007265

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Regulatory Flags#

DUNS number
078684808
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856571007913BroncTru™ Transbronchial Access ToolAK-82-702025-03-31
00856571007920BroncTru™ Transbronchial Access ToolAK-64-602025-03-31
00856571007937BroncTru™ Transbronchial Access ToolAK-46-552025-03-31
00856571007944BroncTru™ Transbronchial Access ToolAK-91-552025-03-31
00856571007951BroncTru™ Transbronchial Access ToolAK-82-002025-03-31
00856571007968BroncTru™ Transbronchial Access ToolAK-64-002025-03-31
00856571007975BroncTru™ Transbronchial Access ToolAK-46-002025-03-31
00856571007982BroncTru™ Transbronchial Access ToolAK-91-002025-03-31
08565710078012BioStar Transbronchial Aspiration NeedleiS2372024-08-19
08565710078029BioStar Transbronchial Aspiration NeedleiS2272024-08-19
00856571007296Archimedes Access Kit10009-910009-92021-10-04
00856571007241Empower RF Catheter10010100102019-11-01
00856571007036Archimedes System40005400052017-06-27
00856571007104Archimedes Planning System40009400092017-06-27
00856571007128LungPoint Planning System, v3.230009300092017-06-27
00856571007173LungPoint VBN System, V3.230005300052017-06-27
00856571007227Archimedes Access Key10009-110009-12017-12-12
00856571007258Archimedes Access Key, 10-pack10009-210009-22019-02-21
00856571007012FleXNeedle10005-110005-12017-05-12
00856571007029Archimedes Access Kit10009100092017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719872715108MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715115MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715122MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715283MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715290MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04547410520583FUJIFILMFUJIFILM CORPORATIONEOQ2026-01-23
00850048825086Galaxy System (Cart) - RefurbishedNoah Medical CorporationEOQ2025-10-25
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.EOQ2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.EOQ2025-08-04
10810068811510Monarch™ Laptop P17 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
10810068811527Monarch™ Laptop P16 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
04547410513790FUJIFILMFUJIFILM CORPORATIONEOQ2025-05-31
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.EOQ2025-03-03
10810068810605Monarch™ Laptop P17 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
10810068810612Monarch™ Laptop P16 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
04547410520545FUJIFILMFUJIFILM CORPORATIONEOQ2024-05-15
10810068810834Bronchoscope Fluidics TubingAuris Health, Inc.EOQ2024-05-05
10810068810865Monarch BronchoscopeAuris Health, Inc.EOQ2024-05-05
10810068810872Bronchoscope Sheath ValveAuris Health, Inc.EOQ2024-05-05
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
10818634025118AmbuBosma EnterprisesEOQ2023-05-01
10818634025132AmbuBosma EnterprisesEOQ2023-05-01
10818634025156AmbuBosma EnterprisesEOQ2023-05-01
10818634025163AmbuBosma EnterprisesEOQ2023-05-01
00850023925206WiScope®Otu Medical Inc.EOQ2023-04-30
00850023925213WiScope®Otu Medical Inc.EOQ2023-04-30
00850023925220WiScope®Otu Medical Inc.EOQ2023-04-30
00879123008541BFlex™Verathon Medical (Canada) ULCEOQ2023-04-03