510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GCLClass II

Esophagoscope, General & Plastic Surgery

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

GCL is the FDA product code for Esophagoscope, General & Plastic Surgery, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "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)". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GCL
Device name
Esophagoscope, General & Plastic Surgery
FDA 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).
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code GCL

By decision year
4 clearances under product code GCL with a decision year between 1992 and 1995, 1995 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GCL by decision year
YearClearances
19921
19941
19952

Applicants with the most clearances

Product code GCL
Applicants holding the most 510(k) clearances under product code GCL
ApplicantClearances
Pentax Precision Instrument Corp.2
C.R. Bard Inc1
Phx Technologies Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code