Amsco Harmony Surgical Lighting and Media System
FDA 510(k) K013242 · STERIS Corporation
510(k) numberK013242
Submission
- Device name
- Amsco Harmony Surgical Lighting and Media System
- Applicant
- STERIS Corporation
Montgomery, AL, US - Received
- September 28, 2001
- Decision date
- December 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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
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| 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 |
| K010724 | Sola 700,SOLA 500, Sola 300FTD · Abbreviated | Drager Medizintechnik GmbH | 06/07/2001SE |
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Questions and answers
When was Amsco Harmony Surgical Lighting and Media System cleared by the FDA?
Amsco Harmony Surgical Lighting and Media System (K013242) received a 510(k) decision of Substantially Equivalent on December 13, 2001, 76 days after the submission was received.
What is the product code of K013242?
The FDA product code is FTD – Lamp, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4580.