Chick Surigical Light
FDA 510(k) K860739 · Professional Medical Products, Inc.
510(k) numberK860739
Submission
- Device name
- Chick Surigical Light
- Applicant
- Professional Medical Products, Inc.
Greenwood, SC, US - Received
- February 27, 1986
- Decision date
- March 28, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FSY – Light, Surgical, Ceiling Mounted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142984 | Leo MinorFSY · Traditional | Sunnex, Inc. | 10/29/2014SE |
| K142076 | Claveguard Freedom Surgical LightFSY · Traditional | Dickson & Dickson Healthcare (Us), Inc. | 09/30/2014SE |
| K140812 | MI-750 Procedural/Minor Surgical LightFSY · Traditional | Medical Illumination International, Inc. | 08/07/2014SE |
| K132551 | ZF 720FSY · Traditional | Umbel Corporation | 06/30/2014SE |
| K140930 | Vida LED Surgical Lighting System, V SeriesFSY · Traditional | Convida Healthcare & Systems Corporation | 06/09/2014SE |
| K140461 | Mach LED 2MCFSY · Special | Dr. Mach GmbH & Co. KG | 04/03/2014SE |
| K140460 | Mach LED 2SCFSY · Special | Dr. Mach GmbH & Co. KG | 04/03/2014SE |
| K132747 | Visum Blade LED Surgical Lighting SystemFSY · Traditional | Stryker Communications | 12/30/2013SE |
| K132307 | Vida LED Surgical Lighting SystemFSY · Traditional | Convida Healthcare & Systems Corporation | 11/05/2013SE |
| K131893 | Amico Ce Series Surgical Lights, Mira LED Series Minor Surgical LightsFSY · Traditional | Ajw Technology Consultants, Inc. | 10/30/2013SE |
More from Ajw Technology Consultants, 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 |
| K862010 | Chick Surgical LightFTA · Traditional | 06/09/1986SE |
| 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 Surigical Light cleared by the FDA?
Chick Surigical Light (K860739) received a 510(k) decision of Substantially Equivalent on March 28, 1986, 29 days after the submission was received.
What is the product code of K860739?
The FDA product code is FSY – Light, Surgical, Ceiling Mounted, a Class II (moderate risk) device regulated under 21 CFR 878.4580.