Swiss Lithoclast Master Handpiece and 3.2 MM Probe
FDA 510(k) K974164 · Medical Device Consultants, Inc.
510(k) numberK974164
Submission
- Device name
- Swiss Lithoclast Master Handpiece and 3.2 MM Probe
- Applicant
- Medical Device Consultants, Inc.
North Attleboro, MA, US - Received
- November 5, 1997
- Decision date
- December 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFK – Lithotriptor, Electro-Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4480
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Swiss Lithoclast Master Handpiece and 3.2 MM Probe cleared by the FDA?
Swiss Lithoclast Master Handpiece and 3.2 MM Probe (K974164) received a 510(k) decision of Substantially Equivalent on December 18, 1997, 43 days after the submission was received.
What is the product code of K974164?
The FDA product code is FFK – Lithotriptor, Electro-Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.4480.