Esophagoscope, General & Plastic Surgery

Device Code: 1932

Product Code(s): GCL

Definition: If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 FR 26807, Available At Https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Device Classification Information

Device Type ID1932
Device NameEsophagoscope, General & Plastic Surgery
Regulation DescriptionEndoscope And Accessories.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Urology And Lithotripsy Devices Branch (ULDB)
Submission Type510(k)
CFR Regulation Number876.1500 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGCL
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID1932
DeviceEsophagoscope, General & Plastic Surgery
Product CodeGCL
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEndoscope And Accessories.
CFR Regulation Number876.1500 [🔎]
Device Problems
Break
7
Device Issue
4
Total Device Problems 11
TPLC Last Update: 2019-04-02 20:02:11

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