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510(k) Data Aggregation
K Number
K091838Device Name
OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK
Manufacturer
OBP MEDICAL
Date Cleared
2009-12-04
(165 days)
Product Code
HIH, HET, ODC
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
OBP MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OBP Self-Sealing Endoscopic Seal is a single use, sterile endoscopic introducer seal. It is affixed to the proximal port of the endoscope working channel. It prevents efflux of distention fluid when the channel is not being used or when instruments are passed through the working channel of the endoscope. The seal may be used with following types of endoscopes: hysteroscope, laparoscope, cystoscope, and colonoscope.
Device Description
The OBP Self-Sealing Endoscopic Seal is a single use, sterile endoscopic introducer seal. It is affixed to the proximal port of the endoscope working channel. It prevents efflux of distention fluid when the channel is not being used or when instruments are passed through the working channel of the endoscope. The seal may be used with following types of endoscopes: hysteroscope, laparascope, cystoscope, and colonoscope. The seal comes with 4 different size channels to accommodate different size instruments. They are: 0.6mm, 1.2mm, 1.6mm, and 2.0mm. The 4 different seals are marked with different colored bands: yellow (0.6mm seal), light pink (1.2mm seal), green (1.6mm seal), and blue (2.0mm seal).
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