Synthes Light Guide
FDA 510(k) K993314 · Synthes (Usa)
510(k) numberK993314
Submission
- Device name
- Synthes Light Guide
- Applicant
- Synthes (Usa)
West Chester, PA, US - Received
- October 4, 1999
- Decision date
- December 6, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FQP – Lamp, Operating-Room
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001223 | Aculux, Model AX3001, AX3002FQP · Traditional | Aculux | 06/23/2000SE |
| K781581 | Surgical Light 22 SeriesFQP · Traditional | American Sterilizer Co. | 10/17/1978SE |
| K770812 | Handles, Light, Surgical, SteoileFQP · Traditional | Sybron Corp. | 05/23/1977SE |
| K761018 | Surgical Light - Challenge 22 SeriesFQP · Traditional | Amsco Co. | 01/26/1977SE |
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Questions and answers
When was Synthes Light Guide cleared by the FDA?
Synthes Light Guide (K993314) received a 510(k) decision of Substantially Equivalent on December 6, 1999, 63 days after the submission was received.
What is the product code of K993314?
The FDA product code is FQP – Lamp, Operating-Room, a Class II (moderate risk) device regulated under 21 CFR 878.4580.