Collings Knife Electrode, 27.0 Fr

Collings Knife Electrode, 27.0 Fr
NA - 0502270800

An 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.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Ethylene Oxide
• Hydrogen Peroxide
• Moist Heat or Steam Sterilization

Code: FAS

Device Name: Electrode, Electrosurgical, Active, Urological

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.4300

Third Party Flag: Y

Medical Specialty: GU

Code: HIH

Device Name: Hysteroscope (And Accessories)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OB

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 884.1690

Third Party Flag: Y

Medical Specialty: OB

Code: KQT

Device Name: Evacuator, Gastro-Urology

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.4370

Third Party Flag: N

Medical Specialty: GU

Code: FAJ

Device Name: Cystoscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with cystoscope

Definition: To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Intrument guided through urethra for visualization and to perform various procedures.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: bladder, urethra, kidneys

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 07613327054088

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A