Ams Foreign Body Extrator
FDA 510(k) K972091 · American Medical Systems, Inc.
510(k) numberK972091
Submission
- Device name
- Ams Foreign Body Extrator
- Applicant
- American Medical Systems, Inc.
Minnetonka, MN, US - Received
- June 4, 1997
- Decision date
- August 29, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFL – Dislodger, Stone, Basket, Ureteral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4680
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Ams Foreign Body Extrator cleared by the FDA?
Ams Foreign Body Extrator (K972091) received a 510(k) decision of Substantially Equivalent on August 29, 1997, 86 days after the submission was received.
What is the product code of K972091?
The FDA product code is FFL – Dislodger, Stone, Basket, Ureteral, Metal, a Class II (moderate risk) device regulated under 21 CFR 876.4680.