Uropass Ureteral Access Sheath, Model 61224
FDA 510(k) K051593 · Acmi Corporation
510(k) numberK051593
Submission
- Device name
- Uropass Ureteral Access Sheath, Model 61224
- Applicant
- Acmi Corporation
Southborough, MA, US - Received
- June 16, 2005
- Decision date
- September 2, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNY – Accessories, Catheter, G-U
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Uropass Ureteral Access Sheath, Model 61224 cleared by the FDA?
Uropass Ureteral Access Sheath, Model 61224 (K051593) received a 510(k) decision of Substantially Equivalent on September 2, 2005, 78 days after the submission was received.
What is the product code of K051593?
The FDA product code is KNY – Accessories, Catheter, G-U, a Class II (moderate risk) device regulated under 21 CFR 876.5130.