Urethral Suture Guide
FDA 510(k) K950267 · Applied Medical Resources
510(k) numberK950267
Submission
- Device name
- Urethral Suture Guide
- Applicant
- Applied Medical Resources
Launa Hills, CA, US - Received
- January 23, 1995
- Decision date
- January 31, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KOA – Surgical Instruments, G-U, Manual (And Accessories)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Urethral Suture Guide cleared by the FDA?
Urethral Suture Guide (K950267) received a 510(k) decision of Substantially Equivalent on January 31, 1995, 8 days after the submission was received.
What is the product code of K950267?
The FDA product code is KOA – Surgical Instruments, G-U, Manual (And Accessories), a Class I (low risk) device regulated under 21 CFR 876.4730.