Universal Light Handle Cover, Light Handle Cover
FDA 510(k) K150532 · Key Surgical, Inc.
510(k) numberK150532
Submission
- Device name
- Universal Light Handle Cover, Light Handle Cover
- Applicant
- Key Surgical, Inc.
Eden Prairie, MN, US - Received
- March 2, 2015
- Decision date
- September 22, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTA – Light, Surgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FTA
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|---|---|---|---|
| K142386 | Operating Room Light Handle AdapterFTA · Traditional | Litex Manufacturing, Inc. | 09/29/2014SE |
| K133554 | Surgical Light Handle CoverFTA · Special | Microtek Medical, Inc. an Ecolab Company | 04/08/2014SE |
| K133413 | Idss SLCFTA · Traditional | Black Diamond Video | 01/07/2014SE |
| K112133 | Oasys Surgical Light ControllerFTA · Traditional | Oasys Healthcare | 03/01/2012SE |
| K102791 | Easysuite Surgical Light Control (Eslc)FTA · Special | Image Stream Medical, Inc. | 11/23/2010SE |
| K081698 | Mainstream or Surgical Light Control (MSLC)FTA · Abbreviated | Image Stream Medical, Inc. | 07/30/2008SE |
| K053321 | Light Guard Light Handle and Light Handle CoverFTA · Traditional | Xodus Medical, Inc. | 01/19/2006SE |
| K051505 | Scb/Steris Or-Light Interface BoxFTA · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/11/2005SE |
| K023704 | Ksea SCB Acc ControlFTA · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/30/2003SE |
| K020640 | Ksea SCB Media ControlFTA · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/28/2002SE |
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|---|---|---|
| K151222 | Cautery Tip CleanerGEI · Traditional | 05/22/2015SE |
| K910328 | Key Comfort GripsFSM · Traditional | 03/06/1991SE |
| K896676 | Key Vascular LoopsKDC · Traditional | 02/27/1990SE |
| K896472 | Key Vascular BootiesMAW · Traditional | 12/14/1989SE |
| K895591 | Silicone Instrument ShodsGDJ · Traditional | 10/20/1989SE |
Questions and answers
When was Universal Light Handle Cover, Light Handle Cover cleared by the FDA?
Universal Light Handle Cover, Light Handle Cover (K150532) received a 510(k) decision of Substantially Equivalent on September 22, 2015, 204 days after the submission was received.
What is the product code of K150532?
The FDA product code is FTA – Light, Surgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4580.