Minor Surgery Light Model 2112
FDA 510(k) K860020 · Adel Medical , Ltd.
510(k) numberK860020
Submission
- Device name
- Minor Surgery Light Model 2112
- Applicant
- Adel Medical , Ltd.
Clackamas, OR, US - Received
- January 3, 1986
- Decision date
- January 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FSS – Light, Surgical, Floor Standing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091246 | Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M)FSS · Abbreviated | Trumpf Medizin Systeme GmbH + Co. KG | 09/28/2009SE |
| K003489 | Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next…FSS · Traditional | Medical Illumination International, Inc. | 02/02/2001SE |
| K984124 | Aesculap Xenon Light SourceFSS · Traditional | Aesculap, Inc. | 02/01/1999SE |
| K981962 | Cuda Products Corp. Model M300 (M-300) LightsourceFSS · Traditional | Cuda Products Co. | 08/18/1998SE |
| K981821 | Ves 3001/2 Dual Output Video IlluminatorFSS · Traditional | Angiolaz, Inc. | 07/29/1998SE |
| K981469 | CERMAX300 LightsourceFSS · Traditional | Cuda Products Co. | 07/09/1998SE |
| K980044 | Xenon 300MXFSS · Traditional | Perkinelmer Optoelectronics | 04/03/1998SE |
| K970886 | Hanaulux Blue 80 HospitalFSS · Traditional | Heraeus Med GmbH | 04/16/1997SE |
| K961971 | Q-5000FSS · Traditional | Stryker Endoscopy | 06/28/1996SE |
| K961074 | Lightsource or IlluminatorFSS · Traditional | Cuda Products Co. | 04/30/1996SE |
More from Cuda Products Co.
| 510(k) | Device | Decision |
|---|---|---|
| K890476 | Adel - Model 986 Infant WarmerFMZ · Traditional | 06/16/1989SE |
| K874610 | Adel Model 2100 Birthing BedHDD · Traditional | 01/21/1988SE |
| K871475 | Sololift - Patient Transfer StretcherFMR · Traditional | 05/11/1987SE |
| K861030 | Labor-Delivery Stretch/BedKNC · Traditional | 04/23/1986SE |
| K833321 | Labor/Delivery/Recovery Bed LDR-600KNC · Traditional | 11/14/1983SE |
| K810886 | Adel Medical Birthing Bed, #LD-500HDD · Traditional | 04/23/1981SE |
| K801622 | Adel Medical Birthing Bed, Mod. LD-400KNC · Traditional | 08/14/1980SE |
Questions and answers
When was Minor Surgery Light Model 2112 cleared by the FDA?
Minor Surgery Light Model 2112 (K860020) received a 510(k) decision of Substantially Equivalent on January 24, 1986, 21 days after the submission was received.
What is the product code of K860020?
The FDA product code is FSS – Light, Surgical, Floor Standing, a Class II (moderate risk) device regulated under 21 CFR 878.4580.