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Found 7 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

GYNECOLOGICAL LAPAROSCOPES

Manufacturer

GLOBAL ENDOSCOPY, INC.

Date Cleared

2001-07-22

(226 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

Manufacturer

GLOBAL ENDOSCOPY, INC.

Date Cleared

2001-07-22

(226 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

Manufacturer

GLOBAL ENDOSCOPY, INC.

Date Cleared

2001-07-20

(221 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

Manufacturer

GLOBAL ENDOSCOPY, INC.

Date Cleared

2001-04-09

(119 days)

Product Code

Regulation Number

Type

Panel

Ear Nose & Throat

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

GENERAL SURGICAL LAPAROSCOPES

Manufacturer

GLOBAL ENDOSCOPY, INC.

Date Cleared

2001-03-07

(89 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

Manufacturer

GLOBAL ENDOSCOPY, INC.

Date Cleared

2001-02-22

(76 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

Manufacturer

GLOBAL ENDOSCOPY, INC.

Date Cleared

2001-02-22

(76 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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