Endosopic Stene Manipulating Balloon
FDA 510(k) K850489 · Mill-Rose Laboratory
510(k) numberK850489
Submission
- Device name
- Endosopic Stene Manipulating Balloon
- Applicant
- Mill-Rose Laboratory
Mentor, OH, US - Received
- February 8, 1985
- Decision date
- April 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LQR – Dislodger, Stone, Biliary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
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| K182381 | Wilson-Cook Mini BasketLQR · Traditional | Wilson-Cook Medical, Inc. | 10/30/2018SE |
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Questions and answers
When was Endosopic Stene Manipulating Balloon cleared by the FDA?
Endosopic Stene Manipulating Balloon (K850489) received a 510(k) decision of Substantially Equivalent on April 22, 1985, 73 days after the submission was received.
What is the product code of K850489?
The FDA product code is LQR – Dislodger, Stone, Biliary, a Class II (moderate risk) device regulated under 21 CFR 876.5010.