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GCL — Esophagoscope, General & Plastic Surgery Class II

FDA Device Classification

Classification Details

Product Code
GCL
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

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).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K951197pentax precision instrumentFE-24X, FIBER ESOPHAGOSCOPEMay 30, 1995
K951198pentax precision instrumentFE-34TH, FIBER ESOPHAGOSCOPEMay 30, 1995
K934510phx technologies5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREADFebruary 17, 1994
K922086c.r. bardBARD BIOPSY FORCEPSOctober 30, 1992