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U.S. Department of Health and Human Services

Product Classification
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Device circumcision device with stapler
Regulation Description Obstetric-gynecologic specialized manual instrument.
Definition To cut and suture / staple the prepuce.
Physical State The circumcision device with a stapler is a manual device that includes a circular cutting blade, a ring-type clamp, and a circumferential stapling mechanism.
Technical Method A manual instrument for cutting, clamping, and suturing/stapling the prepuce for the purpose of performing circumcision.
Target Area Penis
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Gastroenterology/Urology
Product CodeQQR
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.4530
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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