FDA.reportPublic FDA data

hoboat

Primary DI
16955045500118
Brand
hoboat
Company
Jiangsu Hope Biomedical Science&Technology Co.,Ltd.
Model
WZX-8XZWW
Published
2024-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231615000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231615000Disposable Endoscopic BipolarJiangsu Hope Biomedical Science & Technology Co., Ltd.2023-12-05GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16955045500118PackageGS110In Commercial Distribution
26955045500115PackageGS12In Commercial Distribution
06955045500548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695504550011816955045500118
2695504550011526955045500115
06955045500548069550455005486955045500548

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, single-useAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a 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 controlling ring-handles). This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554490786
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06955045517188hoboatWZX-10XZWWS2025-03-06
16955045517185hoboatWZX-10XZWWS2025-03-06
06955045516334hoboatZKN-7CWC2025-02-24
06955045516341hoboatZKN-7XWC2025-02-24
06955045516358hoboatZKN-7JWC2025-02-24
06955045516365hoboatZKN-8CWC2025-02-24
06955045516372hoboatZKN-8XWC2025-02-24
06955045516389hoboatZKN-8JWC2025-02-24
16955045516331hoboatZKN-7CWC2025-02-24
16955045516348hoboatZKN-7XWC2025-02-24
16955045516355hoboatZKN-7JWC2025-02-24
16955045516362hoboatZKN-8CWC2025-02-24
16955045516379hoboatZKN-8XWC2025-02-24
16955045516386hoboatZKN-8JWC2025-02-24
06955045515917hoboatZKN-1CWZ2025-02-21
06955045515924hoboatZKN-1XWZ2025-02-21
06955045515931hoboatZKN-1JWZ2025-02-21
06955045515948hoboatZKN-2CWZ2025-02-21
06955045515955hoboatZKN-2XWZ2025-02-21
06955045515962hoboatZKN-2JWZ2025-02-21

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Primary DI, Brand, Company table
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00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
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00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCGEI2026-06-03
00846338006044Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
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00846338006082Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006099Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006105Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006112Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02