9100 Daystar and 9110 Orbiter Package
FDA 510(k) K781887 · Castle Co.
510(k) numberK781887
Submission
- Device name
- 9100 Daystar and 9110 Orbiter Package
- Applicant
- Castle Co.
Mchenry, IL, US - Received
- November 7, 1978
- Decision date
- December 12, 1978
- 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
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| 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 |
|---|---|---|
| K870975 | Modified Castle PowerclaveFLE · Traditional | 04/17/1987SE |
| K860263 | Castle 7538 Floor Loading WasherLDS · Traditional | 03/05/1986SE |
| K844089 | Castle 7515 Utensil/Glassware WasherLDS · Traditional | 01/14/1985SE |
| K834048 | Bovie Conductive Adhes-Disper-ElectroGEI · Traditional | 04/04/1984SE |
| K833074 | Castle Tec-Test S.M.A.R.T. PackJOJ · Traditional | 11/07/1983SE |
| K831595 | Castle Model 3341 & 3441 & 4141 Gas AerFLI · Traditional | 06/15/1983SE |
| K792660 | 1500 Eo Exhaust HoodFLF · Traditional | 01/29/1980SE |
| K792649 | Unispore-Biological IndicatorsFRC · Traditional | 01/29/1980SE |
| K790677 | Eo Evacuating System IFLI · Traditional | 05/07/1979SE |
| K781484 | Castle Model 3146 Gas AeratorFLI · Traditional | 10/27/1978SE |
Questions and answers
When was 9100 Daystar and 9110 Orbiter Package cleared by the FDA?
9100 Daystar and 9110 Orbiter Package (K781887) received a 510(k) decision of Substantially Equivalent on December 12, 1978, 35 days after the submission was received.
What is the product code of K781887?
The FDA product code is FSY – Light, Surgical, Ceiling Mounted, a Class II (moderate risk) device regulated under 21 CFR 878.4580.