Search Results
Found 2 results
510(k) Data Aggregation
K Number
K070913Device Name
SELF-LIGHT DISPOSABLE ANOSCOPE
Manufacturer
SAPIMED S.P.A.
Date Cleared
2007-08-10
(130 days)
Product Code
FER
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SAPIMED S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sapimed Self Ligh®t Disposable Anoscopes are intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Device Description
The Sapimed Self Light ® Disposable Anoscopes are clear, transparent plastic anoscopes in a range of sizes to suit varying clinical needs. Illumination is provided by either coldlight source GLF 100 or pen-light. The anoscopes are provided in the following configurations: Models A.4018 and 4019 are clear anscopes for a clear and easy rectal examination. Models A.4023 and 4024 are anoscopes for examination and use in surgical procedures. The Self-Light® Disposable Operating Anoscopes are clear, transparent disposable anoscopes for various proctological procedures. Illumination is provided by either coldlight source GLF 100 or pen-light. Model A.4081 is an operating anoscopes with a curved shape, transparency and length suitable for open and close hemorrhoiectomy, spincterotomy , coleo/ileo anastamosis, anoplasty, etc. Model A.4082 Basile's cone shaped operating anoscope has a graduated scale visible on the internal part of the instrument. ModelA.4083 The Beak is a surgical anoscope with a closed and rounded tip and a fulllength open channel 2-2.5cm wide
Ask a Question
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?
Applicant Name (Manufacturer) :
SAPIMED S.P.A.
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.
Ask a Question
Page 1 of 1