SURGICAL HEADLIGHT
FDA 510(k) clearance K061690 · decided 2006-09-15
Clearance details
- K-number
- K061690
- Device name
- SURGICAL HEADLIGHT
- Applicant
- Gulf Medical Fiberoptics
- Decision
- Substantially Equivalent
- Date received
- 2006-06-15
- Decision date
- 2006-09-15
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- FST
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Oldsmar, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Gulf Medical Fiberoptics
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 |
|---|---|---|
| TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End (K200874) | Innovasis, Inc. | 2020-06-30 |
| ENDO-CORD (K141330) | Enroxtech, Inc. | 2014-12-15 |
| LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 (K122637) | Stryker Spine | 2012-11-01 |
| EIGR SURGICAL ILLUMINATION SYSTEM (K113697) | Invuity, Inc. | 2012-02-10 |
| CABLECAP (K113330) | Sensormed | 2012-01-12 |
| ISOLED AC-POWERED LED HEADLIGHT SYSTEM (K102266) | Isolux, LLC | 2010-09-24 |
| CABLECAP MODEL: WLF, STZ, ACM (K101496) | Sensormed | 2010-09-14 |
| 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS (K100388) | Medical Illumination International, Inc. | 2010-06-22 |
| HARMONY VLED SURGICAL LIGHTNING SYSTEM (K100395) | STERIS Corporation | 2010-03-17 |
| CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST (K093386) | Bfw, Inc. | 2010-01-28 |
| INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM (K090070) | Invuity, Inc. | 2009-04-22 |
| RETRACTOR LITE (K083710) | Thomas Surgical Instruments, Inc. | 2009-02-23 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA U.S.A.* Mode recall (Z-0831-2012) | Gulf Medical Fiberoptics, Inc. | 2012-01-20 |