Biopsy Forceps, (Non-Rigid)
FDA 510(k) K896146 · Portlyn Corp.
510(k) numberK896146
Submission
- Device name
- Biopsy Forceps, (Non-Rigid)
- Applicant
- Portlyn Corp.
Moultonboro, NH, US - Received
- October 23, 1989
- Decision date
- March 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)EOQ · Special | Karl Storz SE & CO. KG | 12/05/2025SE |
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More from Intuitive Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970083 | Dynabite Hot Gi Biopsy ForcepsKGE · Traditional | 06/17/1997SE |
| K951447 | Dynabite Cardiovascular Biopsy ForcepsDWZ · Traditional | 07/27/1995SE |
| K952391 | Dynabite Urological ForcepsFCL · Traditional | 06/01/1995SE |
| K944245 | Dynabite Laparoscopic ForcepsHET · Traditional | 11/15/1994SE |
| K934506 | Dynabite Hysteroscopic ForcepsHET · Traditional | 03/22/1994SE |
| K901300 | Biopsy ForcepsDWZ · Traditional | 06/29/1990SE |
| K896147 | Biopsy Forcep (Non-Electric)FCL · Traditional | 04/16/1990SE |
Questions and answers
When was Biopsy Forceps, (Non-Rigid) cleared by the FDA?
Biopsy Forceps, (Non-Rigid) (K896146) received a 510(k) decision of Substantially Equivalent on March 9, 1990, 137 days after the submission was received.
What is the product code of K896146?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.