DISPOSABLE GRASPING FORCEPS (BASKET TYPE)
DISPOSABLE GRASPING FORCEPS (BASKET TYPE) - FG-33W
Device Description
A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. 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: FBN
Device Name: Choledochoscope And Accessories, Flexible/Rigid
Device Class: 2
Physical State: endoscope, accessories associated with choledochoscope
Definition: to examine and perform procedures within the bile ducts. 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: instrument guided laparoscopically or through the esophagus into the biliary tree
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: bile ducts
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 14953170031356
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04953170031359
Package Quantity: 2
Package Discontinue Date: 6/23/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 04953170031359
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