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510(k) Data Aggregation
K Number
K070915Device Name
SAPIMED DISPOSABLE SIGMOIDOSCOPE
Manufacturer
SAPIMED S.P.A.
Date Cleared
2007-07-06
(95 days)
Product Code
KDM, KOG
Regulation Number
876.1500Why did this record match?
Product Code :
KDM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SAPIMED's Sigmoidoscopes are used to examine the rectum and lower bowel and, using additional accessories, perform various diagnostic and/or therapeutic procedures.
Device Description
The Proctoscopy set consists of a multi-use plastic Grip (Ref. A.4131) and a choice of 3 different single use Insertion Tubes (Ref. A.4113, A.4120, A.4125). Each insertion tube comes with a matching obturator to facilitate the atraumatic insertion of the tube into the rectum. The multi-use plastic Grip (Ref. A.4131) consists of the following elements: 1. A hollow handle designed to connect to the light source (either a fiberoptic cable or a pen-light). 2. A circular frontal opening designed to connect to the Insertion Tube. 3. A posterior hinged closure containing both the lens and the insufflator attachment. The insufflator is a hand squeeze ball with a one-way valve as also used in manual blood pressure measuring devices. The Sigmoidoscope Kit MRP (ref. A.4522) consists of a Rigid Proctosigmoidoscope insertion tube and a plastic grip.
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