MI-15 Exam Surgical Light
FDA 510(k) K930897 · Medical Illumination, Inc.
510(k) numberK930897
Submission
- Device name
- MI-15 Exam Surgical Light
- Applicant
- Medical Illumination, Inc.
Arleta, CA, US - Received
- February 22, 1993
- Decision date
- June 25, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K133425 | Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical LightFTD · Special | Engineered Medical Solutions Co., LLC | 12/05/2013SE |
| 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 |
More from STERIS Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K931646 | MI-4 Variable Spot LightKZF · Traditional | 08/19/1993SE |
| K931026 | MI-5 Diagnostic LightKZF · Traditional | 08/19/1993SE |
| K925710 | M.E.D. LightKZF · Traditional | 06/04/1993SE |
| K922282 | Illuminator Viii Ultra/SpotKZF · Traditional | 03/04/1993SE |
| K922278 | Illuminator IIIKZF · Traditional | 03/04/1993SE |
| K922281 | Illuminator Vii Mini/Spot LightKZF · Traditional | 02/05/1993SE |
| K922280 | Illuminator Vii Mini/Lum LightKZF · Traditional | 02/05/1993SE |
| K922277 | Illuminator IIKZF · Traditional | 02/05/1993SE |
| K922279 | Illuminator IV Minor Surgery LightFSW · Traditional | 09/02/1992SE |
Questions and answers
When was MI-15 Exam Surgical Light cleared by the FDA?
MI-15 Exam Surgical Light (K930897) received a 510(k) decision of Substantially Equivalent on June 25, 1993, 123 days after the submission was received.
What is the product code of K930897?
The FDA product code is FTD – Lamp, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4580.