Mill-Rose Rotatable Polypectomy Snare
FDA 510(k) K951600 · Mill-Rose Laboratory
510(k) numberK951600
Submission
- Device name
- Mill-Rose Rotatable Polypectomy Snare
- Applicant
- Mill-Rose Laboratory
Mentor, OH, US - Received
- April 7, 1995
- Decision date
- December 18, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 510(k) | Device | Decision |
|---|---|---|
| K983124 | Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Cytology Procedural KitEOQ · Traditional | 10/30/1998SE |
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| K971275 | Mill-Rose Disposable Polypectomy SnareFDI · Traditional | 05/23/1997SE |
| K962736 | Mill-Rose Laryngoscopic Injection NeedleEOQ · Traditional | 07/29/1996SE |
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| K954519 | Wang Transendoscopic Aspiration NeedleFBK · Traditional | 12/22/1995SE |
| K954745 | Mill-Rose Rigid Scope Cleaning BrushesFEB · Traditional | 11/27/1995SE |
| K951051 | Rite-Bite Biopsy ForcepsEOQ · Traditional | 03/24/1995SE |
| K951048 | Rite-Bite Biopsy ForcepsFCL · Traditional | 03/15/1995SE |
| K950559 | Diener Retrieval DevicesFCL · Traditional | 02/16/1995SE |
Questions and answers
When was Mill-Rose Rotatable Polypectomy Snare cleared by the FDA?
Mill-Rose Rotatable Polypectomy Snare (K951600) received a 510(k) decision of Substantially Equivalent on December 18, 1995, 255 days after the submission was received.
What is the product code of K951600?
The FDA product code is FDI – Snare, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4300.