FTD — Lamp, Surgical Class II
FDA product code FTD covers "Lamp, Surgical", 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
- FTD
- 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 |
|---|---|---|---|
| K133425 | engineered medical solutions co | SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL | December 5, 2013 |
| K130513 | maquet | VOLISTA 400; VOLISTA 600 | May 8, 2013 |
| K123776 | drager medical | POLARIS 100/200 | March 8, 2013 |
| K111020 | atricure | ATRICURE DISSECTOR | June 9, 2011 |
| K100234 | hillusa | HM-LAMP II | July 8, 2010 |
| K100884 | howmedica osteonics | STRYKER KNIFELIGHT | June 25, 2010 |
| K071180 | engineered medical solutions co | SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 | June 20, 2007 |
| K053364 | waldmann lighting | HALUX IRIS EXAMINATION AND SURGICAL LAMP | February 23, 2006 |
| K041681 | atricure | ATRICURE DISSECTOR | July 1, 2004 |
| K013242 | steris corporation | AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM | December 13, 2001 |
| K010724 | drager medizintechnik | SOLA 700,SOLA 500, SOLA 300 | June 7, 2001 |
| K003423 | st. francis medical equipment co | ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 | February 22, 2001 |
| K981717 | stryker instruments | STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR | June 30, 1998 |
| K961122 | stryker instruments | STRYKER KNIFELIGHT | August 22, 1996 |
| K954263 | ophthalmic technologies | XE-LITE | October 18, 1995 |
| K942553 | burton medical products | GENESIS | June 23, 1994 |
| K931675 | medline industries | MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS | February 22, 1994 |
| K932451 | heraeus instruments | HANAULUX 2005 SURGICAL LIGHT | November 12, 1993 |
| K930897 | medical illumination | MI-15 EXAM SURGICAL LIGHT | June 25, 1993 |
| K895715 | w.c. heraeus | HANAULUX(R) 2000 | October 13, 1989 |