Metal Halide Light Source, Models MV-9088-T, MV-9088
FDA 510(k) K012265 · Circon Video
510(k) numberK012265
Submission
- Device name
- Metal Halide Light Source, Models MV-9088-T, MV-9088
- Applicant
- Circon Video
Santa Barbara, CA, US - Received
- July 19, 2001
- Decision date
- October 17, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FCW – Light Source, Fiberoptic, Routine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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| K011849 | MICRO-6-SERIES (MR-6, MR-6L) Ureteroscopes, MRO-6 Series (MR-633, MR-642) Ureteroscopes…FGB · Traditional | 12/10/2001SE |
| K012929 | Flexible Pediatric Cystoureteroscope, Model Aur- 735FAJ · Traditional | 11/19/2001SE |
| K012951 | APN-2 USA Series Flexible CholedochoscopeFGB · Traditional | 11/09/2001SE |
| K012925 | DUR-8, Models DUR-8FGB · Traditional | 11/07/2001SE |
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Questions and answers
When was Metal Halide Light Source, Models MV-9088-T, MV-9088 cleared by the FDA?
Metal Halide Light Source, Models MV-9088-T, MV-9088 (K012265) received a 510(k) decision of Substantially Equivalent on October 17, 2001, 90 days after the submission was received.
What is the product code of K012265?
The FDA product code is FCW – Light Source, Fiberoptic, Routine, a Class II (moderate risk) device regulated under 21 CFR 876.1500.