Synergetics Synerlight Fiber Optic Lightsource
FDA 510(k) K032598 · Synergetics, Inc.
510(k) numberK032598
Submission
- Device name
- Synergetics Synerlight Fiber Optic Lightsource
- Applicant
- Synergetics, Inc.
St. Charles, MO, US - Received
- August 25, 2003
- Decision date
- November 24, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MPA – Endoilluminator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Synergetics Synerlight Fiber Optic Lightsource cleared by the FDA?
Synergetics Synerlight Fiber Optic Lightsource (K032598) received a 510(k) decision of Substantially Equivalent on November 24, 2003, 91 days after the submission was received.
What is the product code of K032598?
The FDA product code is MPA – Endoilluminator, a Class II (moderate risk) device regulated under 21 CFR 876.1500.