Storz S6000 Light Source
FDA 510(k) K905376 · Storz Instrument Co.
510(k) numberK905376
Submission
- Device name
- Storz S6000 Light Source
- Applicant
- Storz Instrument Co.
St. Louis, MO, US - Received
- November 30, 1990
- Decision date
- January 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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Questions and answers
When was Storz S6000 Light Source cleared by the FDA?
Storz S6000 Light Source (K905376) received a 510(k) decision of Substantially Equivalent on January 23, 1991, 54 days after the submission was received.
What is the product code of K905376?
The FDA product code is FCW – Light Source, Fiberoptic, Routine, a Class II (moderate risk) device regulated under 21 CFR 876.1500.