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Found 2 results
510(k) Data Aggregation
K Number
K012198Device Name
GIBBONS STERILE TROCAR KITSManufacturer
Date Cleared
2001-08-09
(27 days)
Product Code
Regulation Number
876.5090Type
SpecialReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
GIBBONS SURGICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Gibbons' Surgical Corporation Sterile Trocar Kits contain devices intended for use during laparoscopic/ endoscopic surgery under the guidance of a physician.
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text only contains an FDA notification letter regarding a 510(k) premarket notification for a medical device called "Gibbons' Sterile Trocar Kit".
This document does not contain any information about:
- Acceptance criteria or reported device performance. The letter merely states the device is substantially equivalent to a predicate device.
- Study details: No mention of sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input.
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K Number
K010779Manufacturer
Date Cleared
2001-04-10
(26 days)
Product Code
Regulation Number
876.1500Type
SpecialReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
GIBBONS SURGICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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