Light, Surgical, Endoscopic
An endoscopic surgical light is a lighting unit designed to provide illumination through an endoscope during minimally invasive surgical or diagnostic procedures. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FSW, regulated under 21 CFR 878.4580, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- FSW
- Device Class
- FDA class 2
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K022989 | RADLITE TISSUE RETRACTOR SYSTEM | Nov 25, 2002 | Substantially Equivalent | Genzyme Biosurgery |
| K013511 | XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) | Feb 01, 2002 | Substantially Equivalent | Aculux, Inc. |
| K943342 | MEDICAM XENON LIGHT SOURCE | Oct 17, 1994 | Substantially Equivalent | M.P. Video, Inc. |
| K934337 | CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE | Nov 18, 1993 | Substantially Equivalent | Cuda Products Co. |
| K922279 | ILLUMINATOR IV MINOR SURGERY LIGHT | Sep 02, 1992 | Substantially Equivalent | Medical Illumination, Inc. |
| K913135 | LM-300TWIN | Sep 18, 1991 | Substantially Equivalent | Leisegang Medical, Inc. |
| K894319 | MEDICAL DYNAMICS LIGHT SOURCE | Oct 03, 1989 | Substantially Equivalent | Medical Dynamics, Inc. |
| K870898 | ULTRA-LUX LIGHT SOURCE | Mar 18, 1987 | Substantially Equivalent | Medline Industries, Inc. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.