Fritch Ophthalmic Endoscope
FDA 510(k) K855151 · Regtec
510(k) numberK855151
Submission
- Device name
- Fritch Ophthalmic Endoscope
- Applicant
- Regtec
St. Petersburg, FL, US - Received
- December 26, 1985
- Decision date
- February 19, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDB – Endoscope, Fiber Optic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GDB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032283 | Designs for Vision Fiberoptic LightGDB · Special | Designs For Vision, Inc. | 08/20/2003SE |
| K961536 | FlexscopeGDB · Traditional | Matrix Medica, Inc. | 09/18/1996SE |
| K935818 | EndoscopeGDB · Traditional | Cuda Products Co. | 07/13/1994SE |
| K882061 | Olympus GF-UM3/EU-M3GDB · Traditional | Olympus Corp. | 11/15/1988SE |
| K843900 | Focuscope Universal SystemGDB · Traditional | Medical Diagnostics, Ca. | 12/06/1984SE |
| K810007 | Pentax Upper G.I. Fiberscope, #FG-34GDB · Traditional | Pentax Precision Instrument Corp. | 01/15/1981SE |
Questions and answers
When was Fritch Ophthalmic Endoscope cleared by the FDA?
Fritch Ophthalmic Endoscope (K855151) received a 510(k) decision of Substantially Equivalent on February 19, 1986, 55 days after the submission was received.
What is the product code of K855151?
The FDA product code is GDB – Endoscope, Fiber Optic, a Class II (moderate risk) device regulated under 21 CFR 876.1500.