FTA — Light, Surgical, Accessories Class II
FDA product code FTA covers "Light, Surgical, Accessories", a Class II medical device regulated under 21 CFR 878.4580. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FTA
- Device Class
- Class II
- Regulation Number
- 878.4580
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K150532 | key surgical | Universal Light Handle Cover, Light Handle Cover | September 22, 2015 |
| K142386 | litex manufacturing | Operating Room Light Handle Adapter | September 29, 2014 |
| K133554 | microtek medical, inc. an ecolab | SURGICAL LIGHT HANDLE COVER | April 8, 2014 |
| K133413 | black diamond video | IDSS SLC | January 7, 2014 |
| K112133 | oasys healthcare | OASYS SURGICAL LIGHT CONTROLLER | March 1, 2012 |
| K102791 | image stream medical | EASYSUITE SURGICAL LIGHT CONTROL (ESLC) | November 23, 2010 |
| K081698 | image stream medical | MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) | July 30, 2008 |
| K053321 | xodus medical | LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER | January 19, 2006 |
| K051505 | karl storz endoscopy-america | SCB/STERIS OR-LIGHT INTERFACE BOX | August 11, 2005 |
| K023704 | karl storz endoscopy-america | KSEA SCB ACC CONTROL | January 30, 2003 |
| K020640 | karl storz endoscopy-america | KSEA SCB MEDIA CONTROL | May 28, 2002 |
| K020304 | aspen surgical products | DISPOSABLE LIGHT HANDLE AND ADAPTOR | February 14, 2002 |
| K993089 | deroyal cardiovascular | DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER | October 14, 1999 |
| K954940 | mdt biologic | MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE | January 17, 1996 |
| K935102 | burton medical products | SATURN LIGHT | June 27, 1994 |
| K915068 | american medical mfg | PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER | February 6, 1992 |
| K901154 | microbio-medics | MICROTEK'S SURGICAL LAMP HANDLE & COVER | March 20, 1990 |
| K894397 | welcon | WELCON LIGHT HANDLE | August 10, 1989 |
| K890866 | transmedical | TC SYSTEM-HANDLE | March 14, 1989 |
| K890867 | transmedical | TC SYSTEM-COVER | March 14, 1989 |