American Catheter Poly-Snare
FDA 510(k) K940335 · Intl. Medical, Inc.
510(k) numberK940335
Submission
- Device name
- American Catheter Poly-Snare
- Applicant
- Intl. Medical, Inc.
Fort Myers, FL, US - Received
- January 25, 1994
- Decision date
- July 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FDI – Snare, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was American Catheter Poly-Snare cleared by the FDA?
American Catheter Poly-Snare (K940335) received a 510(k) decision of Substantially Equivalent on July 21, 1994, 177 days after the submission was received.
What is the product code of K940335?
The FDA product code is FDI – Snare, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4300.