TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
FDA 510(k) clearance K200874 · decided 2020-06-30
Clearance details
- K-number
- K200874
- Device name
- TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
- Applicant
- Innovasis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-01
- Decision date
- 2020-06-30
- Days to decision
- 90 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
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
| AXXION LIGHT GUIDE (K082992) | Spinal Elements, Inc. | 2009-02-18 |
Recalls involving this device
No recalls on record reference this clearance.