Ophthalmic Light Pipe Pick
FDA 510(k) K875195 · Trek Medical Products, Inc.
510(k) numberK875195
Submission
- Device name
- Ophthalmic Light Pipe Pick
- Applicant
- Trek Medical Products, Inc.
Mukwonago, WI, US - Received
- December 17, 1987
- Decision date
- March 7, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K100395 | Harmony Vled Surgical Lightning SystemFST · Special | STERIS Corporation | 03/17/2010SE |
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More from Bfw, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K920937 | Computerized PupilHLG · Traditional | 10/02/1992SE |
| K920944 | FTS-200 Gas SystemBSZ · Traditional | 05/29/1992SE |
| K900808 | Rapid Automatic Pneumoperitoneum-IHIF · Traditional | 09/19/1990SE |
| K902784 | Fiber Optic Light SourceEQH · Traditional | 09/12/1990SE |
| K895813 | Glaucoma Mechanical TrephineHQE · Traditional | 04/30/1990SE |
| K882403 | Ophthalmic Fluid InjectorFMF · Traditional | 09/09/1988SE |
| K864035 | VES-10 Intraocular Scissors DriveHQE · Traditional | 12/15/1986SE |
Questions and answers
When was Ophthalmic Light Pipe Pick cleared by the FDA?
Ophthalmic Light Pipe Pick (K875195) received a 510(k) decision of Substantially Equivalent on March 7, 1988, 81 days after the submission was received.
What is the product code of K875195?
The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.