Flexible Fiberoptic Endoscope
FDA 510(k) K850393 · Microvasive
510(k) numberK850393
Submission
- Device name
- Flexible Fiberoptic Endoscope
- Applicant
- Microvasive
Milford, MA, US - Received
- February 1, 1985
- Decision date
- June 4, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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|---|---|---|
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| K860589 | Inflator/Deflator Piston SyringeKNT · Traditional | 04/07/1986SE |
| K860366 | Challenger Hot Biopsy ForcepsKNS · Traditional | 04/07/1986SE |
| K854238 | Needle W/Stylet for ImplantationGAA · Traditional | 11/13/1985SE |
| K854063 | Microvasive Silicone SprayKCT · Traditional | 10/25/1985SE |
| K851652 | PapillotomeKNS · Traditional | 06/24/1985SE |
| K844769 | Rigid Fiberopitc EndoscopeGCM · Traditional | 01/15/1985SE |
Questions and answers
When was Flexible Fiberoptic Endoscope cleared by the FDA?
Flexible Fiberoptic Endoscope (K850393) received a 510(k) decision of Substantially Equivalent on June 4, 1985, 123 days after the submission was received.