FDA Product Code GCL: Esophagoscope, General & Plastic Surgery
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).
Leading manufacturers include Pentax Precision Instrument Corp., C.R. Bard, Inc. and Phx Technologies Corp..
4
Total
4
Cleared
121d
Avg days
1992
Since
FDA 510(k) Cleared Esophagoscope, General & Plastic Surgery Devices (Product Code GCL)
4 devices
Cleared
May 30, 1995
FE-24X, FIBER ESOPHAGOSCOPE
Pentax Precision Instrument Corp.
Gastroenterology & Urology
75d
Cleared
May 30, 1995
FE-34TH, FIBER ESOPHAGOSCOPE
Pentax Precision Instrument Corp.
Gastroenterology & Urology
75d
Cleared
Feb 17, 1994
5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD
Phx Technologies Corp.
Gastroenterology & Urology
156d
Cleared
Oct 30, 1992
BARD BIOPSY FORCEPS
C.R. Bard, Inc.
Gastroenterology & Urology
179d