Steris Deepsite Fiber Optic Surgical Light
FDA 510(k) K003577 · STERIS Corporation
510(k) numberK003577
Submission
- Device name
- Steris Deepsite Fiber Optic Surgical Light
- Applicant
- STERIS Corporation
Montgomery, AL, US - Received
- November 20, 2000
- Decision date
- January 29, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FST – Light, Surgical, Fiberoptic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Steris Deepsite Fiber Optic Surgical Light cleared by the FDA?
Steris Deepsite Fiber Optic Surgical Light (K003577) received a 510(k) decision of Substantially Equivalent on January 29, 2001, 70 days after the submission was received.
What is the product code of K003577?
The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.