Smith & Nephew Xenon Light Sources and Accessories
FDA 510(k) K994084 · Smith & Nephew, Inc.
510(k) numberK994084
Submission
- Device name
- Smith & Nephew Xenon Light Sources and Accessories
- Applicant
- Smith & Nephew, Inc.
Andover, MA, US - Received
- December 3, 1999
- Decision date
- January 20, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFS – Image, Illumination, Fiberoptic, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access SheathFFS · Traditional | Cook Urological, Inc. | 11/20/2007SE |
| K061622 | PS SeriesFFS · Traditional | Photonic Optische Gerate Gesmbh & Cokg | 03/05/2007SE |
| K063309 | Tru-CableFFS · Traditional | Truphatek International, Ltd. | 01/12/2007SE |
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| K023633 | Sovis Optique's Endoscopic CableFFS · Traditional | Sovis Optique | 12/31/2002SE |
| K001698 | Micro Link Endoscopic Fiber Cable, Model B1-90159FFS · Traditional | Cogent Light Technologies, Inc. | 07/17/2000SE |
| K991323 | Smith & Nephew Subcutaneous IlluminatorFFS · Traditional | Smith & Nephew, Inc. | 07/06/1999SE |
| K983714 | Solartec Source 270, Model # 90123FFS · Traditional | Cogent Light Technologies, Inc. | 12/23/1998SE |
| K982462 | Fiber Optic Endoillumination ProbeFFS · Traditional | Microvision, Inc. | 09/14/1998SE |
| K980636 | Fiber Optic Endoillumination ProbeFFS · Traditional | Dutch Ophthalmic USA, Inc. | 05/20/1998SE |
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Questions and answers
When was Smith & Nephew Xenon Light Sources and Accessories cleared by the FDA?
Smith & Nephew Xenon Light Sources and Accessories (K994084) received a 510(k) decision of Substantially Equivalent on January 20, 2000, 48 days after the submission was received.
What is the product code of K994084?
The FDA product code is FFS – Image, Illumination, Fiberoptic, For Endoscope , a Class II (moderate risk) device regulated under 21 CFR 876.1500.