Mill-Rose Disposable Polypectomy Snare
FDA 510(k) K971275 · Mill-Rose Laboratory
510(k) numberK971275
Submission
- Device name
- Mill-Rose Disposable Polypectomy Snare
- Applicant
- Mill-Rose Laboratory
Mentor, OH, US - Received
- April 7, 1997
- Decision date
- May 23, 1997
- 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 |
| K983122 | Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Combination…EOQ · Traditional | 10/30/1998SE |
| K962736 | Mill-Rose Laryngoscopic Injection NeedleEOQ · Traditional | 07/29/1996SE |
| K960880 | Mill-Rose Blind Microbiology BrushEOQ · Traditional | 04/29/1996SE |
| K954519 | Wang Transendoscopic Aspiration NeedleFBK · Traditional | 12/22/1995SE |
| K951600 | Mill-Rose Rotatable Polypectomy SnareFDI · Traditional | 12/18/1995SE |
| 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 Disposable Polypectomy Snare cleared by the FDA?
Mill-Rose Disposable Polypectomy Snare (K971275) received a 510(k) decision of Substantially Equivalent on May 23, 1997, 46 days after the submission was received.
What is the product code of K971275?
The FDA product code is FDI – Snare, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4300.