DISPOSABLE BIOPSY FORCEPS - FB-212U
Device Description
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 single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 14953170354158
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04953170354151
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 04953170354151
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
Device Id: 54953170354156
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 14953170354158
Package Quantity: 16
Package Discontinue Date: 8/29/2023 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A