Disposable Bipolar Suction Coagulator 7 1/2in. (19cm) 8 Fr
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- Kirwan FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- Disposable Bipolar Suction Coagulator 7 1/2in. (19cm) 8 Fr EUDAMEDDisposable Bipolar Suction Coagulator 7 1/2" (19cm) 8 Fr FDA UDI
- Model / Reference
- 14-9000 EUDAMEDFDA UDI
- Description
- Disposable Bipolar Suction Coagulator 7 1/2" (19cm) 8 Fr FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019101070 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841019101070 EUDAMED
- 510(k) Number
- K960455 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 7.5 Inch FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
This device is a Disposable Bipolar Suction Coagulator, classified under nomenclature code K0201010501 as a Class IIb surgical instrument. It combines suction and bipolar electrosurgical coagulation to remove tissue while simultaneously sealing blood vessels, reducing bleeding during procedures. The insulated, malleable design ensures precise control and adaptability to surgical needs.
The Disposable Bipolar Suction Coagulator 7 1/2in. (19cm) 8 Fr (Model 14-9000) is a single-use, non-sterile device intended for sterilization prior to first use (sterilization method not specified). It is non-implantable, non-latex, and non-reusable, with a gold-plated tip for even heat distribution. Compatible with standard bipolar electrosurgical units, it is regulated under FDA 510K and MDD directives, with a UDI (B-00841019101070) for traceability.
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.
- PlasmaBlade™ — MEDTRONIC NAVIGATION, INC. · Class II
- Victan — Jiangsu Haize Medical Scientific Development Co., Ltd. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Bovie — SYMMETRY SURGICAL INC. · Class II
- Valleylab — Covidien LP · Class II
- A&E Medical / Disposable Suction Coagulator — A & E MEDICAL CORPORATION · Class II
- PlasmaBladeTM — MEDTRONIC NAVIGATION, INC. · Class II
- Victan — Jiangsu Haize Medical Scientific Development Co., Ltd. · Class II
Frequently asked questions
What is the primary purpose of the Disposable Bipolar Suction Coagulator 7 1/2in. (19cm) 8 Fr, and how does it differ from traditional suction tools?
The Disposable Bipolar Suction Coagulator combines suction and bipolar electrosurgical coagulation to simultaneously remove tissue and seal blood vessels during surgery. Unlike traditional suction tools, which only remove fluids or debris, this device reduces bleeding by applying controlled heat to vessels while suctioning, improving precision and minimizing postoperative complications.
Is this device single-use, and if so, how should it be prepared for first-time use?
Yes, this device is explicitly marked as single-use and non-sterile. It must be sterilized prior to its first use, though the specific sterilization method is not detailed in the provided data. Always follow manufacturer guidelines or validated protocols for sterilization to ensure safety and efficacy.
What materials is the device made from, and are there any allergens or compatibility concerns to note?
The device is non-latex and does not contain animal tissues or medicinal products. Its gold-plated tip ensures even heat distribution, but no other material specifications are provided. Compatibility is confirmed with standard bipolar electrosurgical units, so ensure your unit is compatible before use.
What sizes or models are available for this device, and how does the length or French size (Fr) affect its use?
The provided data lists only one model: the Disposable Bipolar Suction Coagulator 7 1/2in. (19cm) 8 Fr (Model 14-9000). The 8 Fr designation refers to its lumen diameter, which influences suction capacity and tissue removal efficiency, while the 19cm length offers reach for deeper surgical sites. This specific size balances precision and accessibility for procedures requiring controlled coagulation and suction.
How can I verify the regulatory compliance and traceability of this device?
This device is regulated under FDA 510K and MDD (Medical Device Directive) directives, with a UDI (B-00841019101070) for traceability. The UDI allows for tracking and verification of authenticity, ensuring compliance with global medical device regulations. Always check the UDI label or packaging for confirmation.
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: Disposable Suction Coagulators - Kirwan Surgical Products, LLC, PDF Disposable Bipolar Suction Coagulators - Kirwan Surgical Products, LLC, Disposable Suction Coagulators - Kirwan Surgical Products, LLC | Kirwan ...
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K960455 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K965241 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00841019101070 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Kirwan Surgical Products LLC
- EUDAMED SRN
- US-MF-000008222
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (3)
- EUDAMED d44933bf-9888-4602-89f6-c56b06762d15 61 fields · synced Sep 19, 2026
- FDA UDI e3fa6bb4-a96e-442c-afe0-da16e071ca43 36 fields · synced May 30, 2026
- FDA 510(k) K960455 1 fields · synced May 18, 2026