Tru-Cable
FDA 510(k) K063309 · Truphatek International, Ltd.
510(k) numberK063309
Submission
- Device name
- Tru-Cable
- Applicant
- Truphatek International, Ltd.
Bonita Springs, FL, US - Received
- November 2, 2006
- Decision date
- January 12, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFS – Image, Illumination, Fiberoptic, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access SheathFFS · Traditional | Cook Urological, Inc. | 11/20/2007SE |
| K061622 | PS SeriesFFS · Traditional | Photonic Optische Gerate Gesmbh & Cokg | 03/05/2007SE |
| K061025 | Accutech Endolite ProbeFFS · Traditional | Accutech Medical Technologies, Inc. | 05/31/2006SE |
| K023633 | Sovis Optique's Endoscopic CableFFS · Traditional | Sovis Optique | 12/31/2002SE |
| K001698 | Micro Link Endoscopic Fiber Cable, Model B1-90159FFS · Traditional | Cogent Light Technologies, Inc. | 07/17/2000SE |
| K994084 | Smith & Nephew Xenon Light Sources and AccessoriesFFS · Traditional | Smith & Nephew, Inc. | 01/20/2000SE |
| K991323 | Smith & Nephew Subcutaneous IlluminatorFFS · Traditional | Smith & Nephew, Inc. | 07/06/1999SE |
| K983714 | Solartec Source 270, Model # 90123FFS · Traditional | Cogent Light Technologies, Inc. | 12/23/1998SE |
| K982462 | Fiber Optic Endoillumination ProbeFFS · Traditional | Microvision, Inc. | 09/14/1998SE |
| K980636 | Fiber Optic Endoillumination ProbeFFS · Traditional | Dutch Ophthalmic USA, Inc. | 05/20/1998SE |
More from Dutch Ophthalmic USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K062523 | Tru-Mr Laryngoscope SetCCW · Traditional | 11/17/2006SE |
Questions and answers
When was Tru-Cable cleared by the FDA?
Tru-Cable (K063309) received a 510(k) decision of Substantially Equivalent on January 12, 2007, 71 days after the submission was received.
What is the product code of K063309?
The FDA product code is FFS – Image, Illumination, Fiberoptic, For Endoscope , a Class II (moderate risk) device regulated under 21 CFR 876.1500.