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510(k) Data Aggregation
K Number
K003995Device Name
SPECULITE/ORALLITEManufacturer
Date Cleared
2001-03-16
(80 days)
Product Code
Regulation Number
872.4630Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SPECULITE/ORALLITE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K963391Device Name
SPECULITEManufacturer
Date Cleared
1997-12-12
(471 days)
Product Code
Regulation Number
884.4530Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SPECULITE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
- Speculoscopy is indicated for use in those women who are currently recommended for cervical screening with pelvic examination and Pap smear.
- Speculoscopy is only to be used as an adjunct to the Pap smear, and only the combination of the two tests affords the clinician improved sensitivity in identifying women with mucosal abnormalities visualized on colposcopy.
- The combined results of the Pap smear with Speculoscopy in the screening examination, designated Pap Plus Speculoscopy, can allow for the identification of more women who are appropriate referrals for colposcopy or close follow up than Pap smear alone.
Device Description
Not Found
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for the Speculite®/Speculoscopy device and its Indications for Use statement. It does not contain information about acceptance criteria or a study proving that acceptance criteria were met. Therefore, I cannot fulfill the request.
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