End-Irrigating Endoilluminator
FDA 510(k) K931546 · Infinitech, Inc.
510(k) numberK931546
Submission
- Device name
- End-Irrigating Endoilluminator
- Applicant
- Infinitech, Inc.
Chesterfield, MO, US - Received
- March 29, 1993
- Decision date
- February 9, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K122637 | Lite Decompression System- Light Cable Model 48089999FST · Traditional | Stryker Spine | 11/01/2012SE |
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| K102266 | Isoled Ac-Powered LED Headlight SystemFST · Traditional | Isolux, LLC | 09/24/2010SE |
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| K100388 | 21ST Century Centurion Exceled and System Two LED Lighting SystemsFST · Traditional | Medical Illumination International, Inc. | 06/22/2010SE |
| K100395 | Harmony Vled Surgical Lightning SystemFST · Special | STERIS Corporation | 03/17/2010SE |
| K093386 | Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FSTFST · Traditional | Bfw, Inc. | 01/28/2010SE |
More from Bfw, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972506 | Infinitech Bullet Endo Illuminated Pick ManipulatorHJM · Traditional | 10/01/1997SE |
| K971950 | Infinitech Multi-Spot Slit Lamp Laser AdapterHQF · Traditional | 08/01/1997SE |
| K951627 | Infinitech High Intensity Xenon Light Source SystemMPA · Traditional | 10/19/1995SE |
| K931264 | Infinitech OtoprobeGEX · Traditional | 03/01/1994SE |
| K935441 | Infinitech Breath EzBWN · Traditional | 02/07/1994SE |
Questions and answers
When was End-Irrigating Endoilluminator cleared by the FDA?
End-Irrigating Endoilluminator (K931546) received a 510(k) decision of Substantially Equivalent on February 9, 1994, 317 days after the submission was received.
What is the product code of K931546?
The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.