Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip
FDA 510(k) K090830 · Laborie Medical Technologies, Ltd.
510(k) numberK090830
Submission
- Device name
- Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip
- Applicant
- Laborie Medical Technologies, Ltd.
Williston, VT, US - Received
- March 26, 2009
- Decision date
- July 21, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FBK – Endoscopic Injection Needle, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
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| K234107 | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)KLA · Traditional | 04/23/2024SE |
| K082614 | Evox Electro Diagnostic DeviceGWF · Traditional | 03/06/2009SE |
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| K073552 | Laborie Urodynamic System with Tetra AccessoryFEN · Traditional | 03/05/2008SE |
| K070331 | Urostym Biofeedback and Stimulation Device and AccessoriesKPI · Traditional | 05/04/2007SE |
| K962009 | UrostymKPI · Traditional | 05/20/1997SE |
| K955856 | Tex-Aid BlueLKY · Traditional | 02/16/1996SE |
| K955810 | U-TexFHA · Traditional | 01/24/1996SE |
Questions and answers
When was Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip cleared by the FDA?
Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip (K090830) received a 510(k) decision of Substantially Equivalent on July 21, 2009, 117 days after the submission was received.
What is the product code of K090830?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.