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510(k) Data Aggregation
K Number
K971125Device Name
ENDO SMARTCAP (100501)
Manufacturer
ENDO SMART CAP CO.
Date Cleared
1997-05-23
(57 days)
Product Code
OCX
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ENDO SMART CAP CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endo SmartCap™ is intended to supply sterile water to series 10, 100 and 130 Olympus endoscopes when connected to a commercially available sterile water bottle.
Device Description
The Endo SmartCap™ consists of two tubes, arranged coaxially, with a fitting on one end and a hottle cap adapter on the other. On one end, the tubes engage a coaxial fitting designed to replicate the fitting of the predicate device and how it engages with the receptacle on the Endoscope. The fitting is designed to receive air from the Endoscope and direct the flow through the annulus between the inner and outer tubes. The opposite end of the outer tube is connected to a bottle cap adapter by means of a compression fitting to form an airtight scal. The inner tube passes through the compression fitting and extends beyond the cap adapter. When assembled with a bottle of sterile water, the device allows air from the Endoscope to pressurize the bottle and motivate water out of the bottle through the inner tube. The inner tube terminates at the coaxial fitting where water is directed through a separate channel of the receptacle to feed the Endoscope. The Endo SmartCap™ is sold as a sterile, single patient use device. It will be individually packaged in a Chevron-style sterile barrier pouch with the product label affixed to the clear side of the package, or the label pre-printed on the Tyvek® side of the pouch.
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