Biopsy Cup, Semi-flexible, 7 Fr.

Biopsy Cup, Semi
NA - 0502777400

A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.

No Data Available

• Length: 41.0 Centimeter

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization
• Ethylene Oxide

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: 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: 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

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

Device Id: 07613327059946

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