Syntec True Light End Irrigating Endoilluminator
FDA 510(k) K973293 · Vaughan Weeks
510(k) numberK973293
Submission
- Device name
- Syntec True Light End Irrigating Endoilluminator
- Applicant
- Vaughan Weeks
Caledonia, WI, US - Received
- September 2, 1997
- Decision date
- November 18, 1997
- 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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| K143123 | Synergetics PHOTON EXMPA · Traditional | Synergetics | 02/24/2015SE |
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| K062895 | Xenon Brightstar Illumination System, Model 1266.XIIIMPA · Special | Dutch Ophthalmic Research Center International BV | 10/13/2006SE |
| K062259 | Iscience Surgical Fiberoptic Illuminator, Model Fi - 100MPA · Traditional | Iscience Surgical | 08/15/2006SE |
More from Iscience Surgical
| 510(k) | Device | Decision |
|---|---|---|
| K973290 | Syntec True Light Endoillumiinator with PickMPA · Traditional | 11/14/1997SE |
Questions and answers
When was Syntec True Light End Irrigating Endoilluminator cleared by the FDA?
Syntec True Light End Irrigating Endoilluminator (K973293) received a 510(k) decision of Substantially Equivalent on November 18, 1997, 77 days after the submission was received.
What is the product code of K973293?
The FDA product code is MPA – Endoilluminator, a Class II (moderate risk) device regulated under 21 CFR 876.1500.