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Found 5 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

CORTEK MINI LAPAROSCOPE

Manufacturer

CORTEK ENDOSCOPY, INC.

Date Cleared

2000-04-13

(83 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

CORTEK ARTHROSCOPE

Manufacturer

CORTEK ENDOSCOPY, INC.

Date Cleared

2000-04-11

(81 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

CORTEK LAPAROSCOPES

Manufacturer

CORTEK ENDOSCOPY, INC.

Date Cleared

2000-03-31

(70 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

CORTEK URETHEROSCOPE

Manufacturer

CORTEK ENDOSCOPY, INC.

Date Cleared

2000-03-03

(42 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

CORTEK CYSTOSCOPE

Manufacturer

CORTEK ENDOSCOPY, INC.

Date Cleared

2000-03-03

(42 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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