Surgical Light 22 Series
FDA 510(k) K781581 · American Sterilizer Co.
510(k) numberK781581
Submission
- Device name
- Surgical Light 22 Series
- Applicant
- American Sterilizer Co.
Mchenry, IL, US - Received
- September 15, 1978
- Decision date
- October 17, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FQP – Lamp, Operating-Room
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001223 | Aculux, Model AX3001, AX3002FQP · Traditional | Aculux | 06/23/2000SE |
| K993314 | Synthes Light GuideFQP · Abbreviated | Synthes (Usa) | 12/06/1999SE |
| K770812 | Handles, Light, Surgical, SteoileFQP · Traditional | Sybron Corp. | 05/23/1977SE |
| K761018 | Surgical Light - Challenge 22 SeriesFQP · Traditional | Amsco Co. | 01/26/1977SE |
More from Amsco Co.
| 510(k) | Device | Decision |
|---|---|---|
| K943288 | Amsco SQ240 Surgical LightFSY · Traditional | 10/17/1994SE |
| K931872 | The Eagle 3017 100% Ethylene Oxide SterilizerFLF · Traditional | 02/07/1994SE |
| K922485 | Chemdi-Vhp Chemical IndicatorJOJ · Traditional | 09/29/1993SE |
| K930493 | Quantum 3080 Surgical TableFQO · Traditional | 06/22/1993SE |
| K905816 | Orthovision TableJEB · Traditional | 03/06/1991SE |
| K896674 | Amsco Quantum LightFSY · Traditional | 01/03/1990SE |
| K895164 | Eagle DSECG · Traditional | 11/17/1989SE |
| K882660 | General Surgical Table and AccessoriesFQO · Traditional | 07/25/1988SE |
| K880198 | Gemini Surgical LightFSS · Traditional | 02/10/1988SE |
| K864846 | Radiographic - Leg SectionKQS · Traditional | 12/24/1986SE |
Questions and answers
When was Surgical Light 22 Series cleared by the FDA?
Surgical Light 22 Series (K781581) received a 510(k) decision of Substantially Equivalent on October 17, 1978, 32 days after the submission was received.
What is the product code of K781581?
The FDA product code is FQP – Lamp, Operating-Room, a Class II (moderate risk) device regulated under 21 CFR 878.4580.