FDA Product Code
FDA Product Code FTA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4580
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K150532 | Universal Light Handle Cover, Light Handle Cover | Key Surgical, Inc. | 2015-09-22 | Traditional | PDF ↗ |
| K142386 | Operating Room Light Handle Adapter | Litex Manufacturing, Inc. | 2014-09-29 | Traditional | PDF ↗ |
| K133554 | SURGICAL LIGHT HANDLE COVER | Microtek Medical, Inc. an Ecolab Company | 2014-04-08 | Special | PDF ↗ |
| K133413 | IDSS SLC | Black Diamond Video | 2014-01-07 | Traditional | PDF ↗ |
| K112133 | OASYS SURGICAL LIGHT CONTROLLER | Oasys Healthcare | 2012-03-01 | Traditional | PDF ↗ |
| K102791 | EASYSUITE SURGICAL LIGHT CONTROL (ESLC) | Image Stream Medical, Inc. | 2010-11-23 | Special | PDF ↗ |
| K081698 | MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) | Image Stream Medical, Inc. | 2008-07-30 | Abbreviated | PDF ↗ |
| K053321 | LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER | Xodus Medical, Inc. | 2006-01-19 | Traditional | PDF ↗ |
| K051505 | SCB/STERIS OR-LIGHT INTERFACE BOX | KARL STORZ Endoscopy-America, Inc. | 2005-08-11 | Traditional | PDF ↗ |
| K023704 | KSEA SCB ACC CONTROL | KARL STORZ Endoscopy-America, Inc. | 2003-01-30 | Traditional | PDF ↗ |
| K020640 | KSEA SCB MEDIA CONTROL | KARL STORZ Endoscopy-America, Inc. | 2002-05-28 | Traditional | PDF ↗ |
| K020304 | DISPOSABLE LIGHT HANDLE AND ADAPTOR | Aspen Surgical Products, Inc. | 2002-02-14 | Traditional | PDF ↗ |
| K993089 | DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER | Deroyal Cardiovascular, Inc. | 1999-10-14 | Traditional | PDF ↗ |
| K954940 | MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE | Mdt Biologic Co. | 1996-01-17 | Traditional | PDF ↗ |
| K935102 | SATURN LIGHT | Burton Medical Products Corp. | 1994-06-27 | Traditional | PDF ↗ |
| K915068 | PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER | American Medical Mfg., Inc. | 1992-02-06 | Traditional | PDF ↗ |
| K901154 | MICROTEK'S SURGICAL LAMP HANDLE & COVER | Microbio-Medics, Inc. | 1990-03-20 | Traditional | PDF ↗ |
| K894397 | WELCON LIGHT HANDLE | Welcon, Inc. | 1989-08-10 | Traditional | PDF ↗ |
| K890867 | TC SYSTEM-COVER | Transmedical Corp. | 1989-03-14 | Traditional | PDF ↗ |
| K890866 | TC SYSTEM-HANDLE | Transmedical Corp. | 1989-03-14 | Traditional | PDF ↗ |
| K890539 | SURE COUNT LIGHT HANDLE COVER | Kleen Test Products | 1989-02-27 | Traditional | PDF ↗ |
| K882132 | LIGHT, SURGICAL ACCESSORIES | Charles Polo & Co., Inc. | 1988-06-15 | Traditional | PDF ↗ |
| K871034 | LCA 2000 | Vistek Corp. | 1987-04-10 | Traditional | PDF ↗ |
| K862010 | CHICK SURGICAL LIGHT | Professional Medical Products, Inc. | 1986-06-09 | Traditional | PDF ↗ |
| K810292 | CAM-WRAP | Medline Industries, Inc. | 1981-03-04 | Traditional | PDF ↗ |
| K780162 | DIGAPHOT PHOTOTHERAPY METER MODEL PT 145 | Cavitron Corp. | 1978-03-27 | Traditional | PDF ↗ |
Product code FTA · Class II · General, Plastic Surgery. Data: openFDA.