Stone Extractor
FDA 510(k) K971123 · Phx Technologies Corp.
510(k) numberK971123
Submission
- Device name
- Stone Extractor
- Applicant
- Phx Technologies Corp.
Denton, TX, US - Received
- March 27, 1997
- Decision date
- June 27, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
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Questions and answers
When was Stone Extractor cleared by the FDA?
Stone Extractor (K971123) received a 510(k) decision of Substantially Equivalent on June 27, 1997, 92 days after the submission was received.
What is the product code of K971123?
The FDA product code is OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered, a Class II (moderate risk) device regulated under 21 CFR 876.1500.