Endoscope, Fiber Optic
The Endoscope, Fiber Optic (product code GDB) is a flexible or rigid endoscope that uses fiber optic technology to transmit light and images, enabling visualization of internal body structures including the gastrointestinal and urological tracts for diagnostic or therapeutic procedures. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification demonstrating substantial equivalence. The device is regulated under 21 CFR 876.1500 in the Gastroenterology, Urology specialty (GU). No special flags apply to this device.
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Basic Information
- Product Code
- GDB
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K032283 | DESIGNS FOR VISION FIBEROPTIC LIGHT | Aug 20, 2003 | Substantially Equivalent | Designs For Vision, Inc. |
| K961536 | FLEXSCOPE | Sep 18, 1996 | Substantially Equivalent | Matrix Medica, Inc. |
| K935818 | ENDOSCOPE | Jul 13, 1994 | Substantially Equivalent | Cuda Products Co. |
| K882061 | OLYMPUS GF-UM3/EU-M3 | Nov 15, 1988 | Substantially Equivalent | Olympus Corp. |
| K855151 | FRITCH OPHTHALMIC ENDOSCOPE | Feb 19, 1986 | Substantially Equivalent | Regtec |
| K843900 | FOCUSCOPE UNIVERSAL SYSTEM | Dec 06, 1984 | Substantially Equivalent | Medical Diagnostics, Ca. |
| K810007 | PENTAX UPPER G.I. FIBERSCOPE, #FG-34 | Jan 15, 1981 | Substantially Equivalent | Pentax Precision Instrument Corp. |