Rite-Bite Biopsy Forceps
FDA 510(k) K951051 · Mill-Rose Laboratory
510(k) numberK951051
Submission
- Device name
- Rite-Bite Biopsy Forceps
- Applicant
- Mill-Rose Laboratory
Mentor, OH, US - Received
- March 6, 1995
- Decision date
- March 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K962736 | Mill-Rose Laryngoscopic Injection NeedleEOQ · Traditional | 07/29/1996SE |
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| 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 |
| K951048 | Rite-Bite Biopsy ForcepsFCL · Traditional | 03/15/1995SE |
| K950559 | Diener Retrieval DevicesFCL · Traditional | 02/16/1995SE |
Questions and answers
When was Rite-Bite Biopsy Forceps cleared by the FDA?
Rite-Bite Biopsy Forceps (K951051) received a 510(k) decision of Substantially Equivalent on March 24, 1995, 18 days after the submission was received.
What is the product code of K951051?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.