Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Cytology Procedural Kit
FDA 510(k) K983124 · Mill-Rose Laboratory
Submission
- Device name
- Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Cytology Procedural Kit
- Applicant
- Mill-Rose Laboratory
Mentor, OH, US - Received
- September 8, 1998
- Decision date
- October 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated…
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More from Intuitive Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983122 | Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Combination…EOQ · Traditional | 10/30/1998SE |
| K971275 | Mill-Rose Disposable Polypectomy SnareFDI · Traditional | 05/23/1997SE |
| 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 Laboratories Transbronchial Needle Aspiration (Tbna) Cytology Procedural Kit cleared by the FDA?
Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Cytology Procedural Kit (K983124) received a 510(k) decision of Substantially Equivalent on October 30, 1998, 52 days after the submission was received.
What is the product code of K983124?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.