Genesis
FDA 510(k) K942553 · Burton Medical Products Corp.
510(k) numberK942553
Submission
- Device name
- Genesis
- Applicant
- Burton Medical Products Corp.
Chatsworth, CA, US - Received
- May 31, 1994
- Decision date
- June 23, 1994
- 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 |
|---|---|---|
| K101537 | Aim 200, Major Surgical LightFSY · Traditional | 09/30/2010SE |
| K042395 | Outpatient III Minor Surgery LightFSY · Traditional | 12/01/2004SE |
| K000639 | Visionary 2000FSY · Traditional | 05/25/2000SE |
| K963682 | Genie' Single Ceiling and Double CeilingFSY · Traditional | 11/13/1996SE |
| K961843 | GenieFSY · Traditional | 08/22/1996SE |
| K935102 | Saturn LightFTA · Traditional | 06/27/1994SE |
| K936088 | Wave Fluorescent MagnifierKZF · Traditional | 04/26/1994SE |
| K931645 | Halux TasklightKZF · Traditional | 08/20/1993SE |
| K901706 | Light, Head, ExaminationKZF · Traditional | 07/19/1990SE |
| K893808 | Model 0450000, Opal Medical Exam LightKZF · Traditional | 08/15/1989SE |
Questions and answers
When was Genesis cleared by the FDA?
Genesis (K942553) received a 510(k) decision of Substantially Equivalent on June 23, 1994, 23 days after the submission was received.
What is the product code of K942553?
The FDA product code is FTD – Lamp, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4580.