Tegress Implant Needle
FDA 510(k) K050688 · C.R. Bard, Inc.
510(k) numberK050688
Submission
- Device name
- Tegress Implant Needle
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- March 17, 2005
- Decision date
- April 6, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was Tegress Implant Needle cleared by the FDA?
Tegress Implant Needle (K050688) received a 510(k) decision of Substantially Equivalent on April 6, 2005, 20 days after the submission was received.
What is the product code of K050688?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.