Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical Light
FDA 510(k) K133425 · Engineered Medical Solutions Co., LLC
510(k) numberK133425
Submission
- Device name
- Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical Light
- Applicant
- Engineered Medical Solutions Co., LLC
Phillipsburg, NJ, US - Received
- November 8, 2013
- Decision date
- December 5, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTD – Lamp, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FTD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130513 | Volista 400; Volista 600FTD · Special | Maquet S.A.S. | 05/08/2013SE |
| K123776 | Polaris 100/200FTD · Abbreviated | Drager Medical GmbH | 03/08/2013SE |
| K111020 | Atricure DissectorFTD · Special | AtriCure, Inc. | 06/09/2011SE |
| K100234 | Hm-Lamp IIFTD · Traditional | Hillusa, Inc. | 07/08/2010SE |
| K100884 | Stryker KnifelightFTD · Traditional | Howmedica Osteonics Corp. | 06/25/2010SE |
| K071180 | Scintillant Surgical Light, Model 2644-01-0001FTD · Traditional | Engineered Medical Solutions Co., LLC | 06/20/2007SE |
| K053364 | Halux Iris Examination and Surgical LampFTD · Traditional | Waldmann Lighting | 02/23/2006SE |
| K041681 | Atricure DissectorFTD · Traditional | AtriCure, Inc. | 07/01/2004SE |
| K013242 | Amsco Harmony Surgical Lighting and Media SystemFTD · Abbreviated | STERIS Corporation | 12/13/2001SE |
| K010724 | Sola 700,SOLA 500, Sola 300FTD · Abbreviated | Drager Medizintechnik GmbH | 06/07/2001SE |
More from Drager Medizintechnik GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K071180 | Scintillant Surgical Light, Model 2644-01-0001FTD · Traditional | 06/20/2007SE |
Questions and answers
When was Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical Light cleared by the FDA?
Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical Light (K133425) received a 510(k) decision of Substantially Equivalent on December 5, 2013, 27 days after the submission was received.
What is the product code of K133425?
The FDA product code is FTD – Lamp, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4580.