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U.S. Department of Health and Human Services

Product Classification

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Device endoscopic grasping/cutting instrument, non-powered
Regulation Description Endoscope and accessories.
Definition To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
Physical State Non-electric and non-magnetic devices. May include: grasping or retrieval forceps, biopsy forceps or other sampling tools, scissors, stone basket, stone dislodger
Technical Method Place through an endoscope to reach desired area.
Target Area various tissues, stones or other foreign bodies within GI and GU tract.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeOCZ
Premarket Review Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons