Single Use Loop Cutter FS-410

Single Use Loop Cutter FS
Single Use Loop Cutter FS-410 - FS-410L

A flexible device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working channel of the endoscope. This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PTS

Device Name: Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Device Class: 2

Physical State: Exemption is limited to disposable, single use non-powered endoscopic grasping/cutting instruments.

Definition: This product code is the class II exempt counterpart of OCZ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

Submission Type ID: 4

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: This product code is the class II exempt counterpart of OCZ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: This product code is the class II exempt counterpart of OCZ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 14953170401036

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170401039

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 04953170401039

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