Chick Surgical Light
FDA 510(k) K862010 · Professional Medical Products, Inc.
510(k) numberK862010
Submission
- Device name
- Chick Surgical Light
- Applicant
- Professional Medical Products, Inc.
Greenwood, SC, US - Received
- May 28, 1986
- Decision date
- June 9, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTA – Light, Surgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K150532 | Universal Light Handle Cover, Light Handle CoverFTA · Traditional | Key Surgical, Inc. | 09/22/2015SE |
| 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 |
More from KARL STORZ Endoscopy-America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K926280 | Standard Nebulizer HeaterCAF · Traditional | 03/22/1994SE |
| K930270 | Patient Preoperative Prep Tray, Single UseLRO · Traditional | 02/17/1994SE |
| K920292 | Various Kits and TraysLRO · Traditional | 01/26/1994SEKD |
| K860739 | Chick Surigical LightFSY · Traditional | 03/28/1986SE |
| K834478 | Chick/Reison Patient Emerg. TrolleyKXJ · Traditional | 02/21/1984SE |
| K830825 | Yield Non-Adherent DressingFRO · Traditional | 05/13/1983SE |
| K822713 | Derm-A-Tec Skin Barrier Film · Traditional | 12/07/1982SE |
| K820413 | Aegis Non-Adherent DressingNAB · Traditional | 03/12/1982SE |
Questions and answers
When was Chick Surgical Light cleared by the FDA?
Chick Surgical Light (K862010) received a 510(k) decision of Substantially Equivalent on June 9, 1986, 12 days after the submission was received.
What is the product code of K862010?
The FDA product code is FTA – Light, Surgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4580.