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

Endoscope, Fiber Optic

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

GDB is the FDA product code for Endoscope, Fiber Optic, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GDB
Device name
Endoscope, Fiber Optic
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
7
Ingested recalls
0

Clearances, product code GDB

By decision year
7 clearances under product code GDB with a decision year between 1981 and 2003, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GDB by decision year
YearClearances
19811
19841
19861
19881
19941
19961
20031

Applicants with the most clearances

Product code GDB
Applicants holding the most 510(k) clearances under product code GDB
ApplicantClearances
Cuda Products Co.1
Designs for Vision, Inc.1
Matrix Medica, Inc.1
Medical Diagnostics, Ca.1
Olympus Corp.1
Pentax Precision Instrument Corp.1
Regtec1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GDB.