SOLA 700,SOLA 500, SOLA 300
FDA 510(k) clearance K010724 · decided 2001-06-07
Clearance details
- K-number
- K010724
- Device name
- SOLA 700,SOLA 500, SOLA 300
- Applicant
- Drager Medizintechnik GmbH
- Decision
- Substantially Equivalent
- Date received
- 2001-03-12
- Decision date
- 2001-06-07
- Days to decision
- 87 days
- Clearance type
- Abbreviated
- Product code
- FTD
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Telford, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Drager Medizintechnik GmbH
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT (K133425) | Engineered Medical Solutions Co., LLC | 2013-12-05 |
| VOLISTA 400; VOLISTA 600 (K130513) | Maquet S.A.S. | 2013-05-08 |
| POLARIS 100/200 (K123776) | Drager Medical GmbH | 2013-03-08 |
| ATRICURE DISSECTOR (K111020) | AtriCure, Inc. | 2011-06-09 |
| HM-LAMP II (K100234) | Hillusa, Inc. | 2010-07-08 |
| STRYKER KNIFELIGHT (K100884) | Howmedica Osteonics Corp. | 2010-06-25 |
| SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 (K071180) | Engineered Medical Solutions Co., LLC | 2007-06-20 |
| HALUX IRIS EXAMINATION AND SURGICAL LAMP (K053364) | Waldmann Lighting | 2006-02-23 |
| ATRICURE DISSECTOR (K041681) | AtriCure, Inc. | 2004-07-01 |
| AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM (K013242) | STERIS Corporation | 2001-12-13 |
| ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 (K003423) | St. Francis Medical Equipment Co., Ltd. | 2001-02-22 |
| STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR (K981717) | Stryker Instruments | 1998-06-30 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 su recall (Z-1850-2014) | Steris Corporation | 2014-06-23 |
| STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm. Intended for local i recall (Z-0414-2010) | Steris Corp | 2009-11-23 |
| Drager Surgical Lights Sola 500 and Sola 700. recall (Z-2212-2009) | Draeger Medical, Inc. | 2009-09-16 |
| Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp recall (Z-0358-04) | Draeger Medical, Inc. | 2004-01-22 |
| Drager Sola 700 Surgical Lamp and Steris Harmony LL 700 Surgical Lamp recall (Z-0359-04) | Draeger Medical, Inc. | 2004-01-22 |