Cover, Biopsy Forceps

Device Code: 1801

Product Code(s): FFF

Device Classification Information

• Device Type ID: 1801
• Device Name: Cover, Biopsy Forceps
• Regulation Description: Gastroenterology-urology Biopsy Instrument.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Urology And Lithotripsy Devices Branch (ULDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 876.1075 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: FFF
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 1801
• Device: Cover, Biopsy Forceps
• Product Code: FFF
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Gastroenterology-urology Biopsy Instrument.
• CFR Regulation Number: 876.1075 [🔎]

Device Problems
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Wilson-Cook Medical Inc.	II	Jan-25-2019

TPLC Last Update: 2019-04-02 19:59:50