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510(k) Data Aggregation
K Number
K121789Device Name
SHANGRING
Manufacturer
WUHU SNNA MEDICAL TREATMENT APPLIANCE TECHNOLOGY C
Date Cleared
2012-08-03
(45 days)
Product Code
HFX
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
WUHU SNNA MEDICAL TREATMENT APPLIANCE TECHNOLOGY C
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ShangRing™ device is indicated for circumcision of adult males, defined as circumferential excision of the foreskin or prepuce at or near the level of the coronal sulcus.
Device Description
The ShangRing is a sterile, single use, disposable circumcision device consisting of two concentric rings made from polycarbonate. The outer ring is formed from two semi-circular halves that are joined together on one end by a hinge, and by interlocking ratchets on the opposite end. The inner ring is lined with a soft silicone band. The ShangRing is available in 14 sizes with inner ring diameters ranging from 26mm to 40mm. A disposable sizing guide is provided to assist in selecting the appropriate size ShangRing. The ShangRing is designed to perform a circumferential crushing of the foreskin (prepuce) between the inner ring and outer ring. The inner ring is placed over the penis, at the level of the coronal sulcus. After local anesthesia, the healthcare practitioner everts the patient's foreskin over the inner ring and the outer ring halves are locked together, sandwiching the foreskin between the two rings which effectively prevents bleeding. Skin forward of the crush line is trimmed away. After the procedure, the ShangRing device remains on the patient for 7 days. After 7 days, the ShangRing is removed by the healthcare practitioner.
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