Laser Bronchoscope
FDA 510(k) K831240 · Eder Instrument Co, Inc.
510(k) numberK831240
Submission
- Device name
- Laser Bronchoscope
- Applicant
- Eder Instrument Co, Inc.
Milwaukee, Wi 53202, US - Received
- April 15, 1983
- Decision date
- July 26, 1983
- 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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| K260382 | MONARCH Platform (MON-000008)EOQ · Traditional | Auris Health, Inc. | 07/25/2026SE |
| K254037 | LungFlow Airway CatheterEOQ · Traditional | Free Flow Medical, Inc. | 07/10/2026SE |
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| K260565 | SmartClip Delivery Catheter (ADR-1715)EOQ · Traditional | Elucent Medical | 05/14/2026SE |
| K252341 | Evis Exera III Bronchovideoscope (Olympus BF-Q190); Evis Exera III Bronchovideoscope…EOQ · Traditional | Olympus Medical Systems Corp. | 04/23/2026SE |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)EOQ · Traditional | MacroLux Medical Technology Co., Ltd. | 04/08/2026SE |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710USEOQ · Traditional | Fujifilm Corporation | 12/12/2025SE |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)EOQ · Special | Karl Storz SE & CO. KG | 12/05/2025SE |
| K252045 | Ion Endoluminal System (IF1000)EOQ · Traditional | Intuitive Surgical, Inc. | 09/23/2025SE |
More from Intuitive Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K843498 | Bipolar Suction ElectrodeGET · Traditional | 12/14/1984SE |
| K843499 | Arthroscopy Leg Holder · Traditional | 10/31/1984SE |
| K843497 | Surgical Knives & ProbesEMF · Traditional | 10/31/1984SE |
| K831255 | Laryngoscope Attachment PH2000EQN · Traditional | 09/12/1983SE |
| K831241 | Laser LaparaxopeHET · Traditional | 06/10/1983SE |
| K822959 | Endoscopic VideosystemFET · Traditional | 10/22/1982SE |
| K802479 | Surgical Knives & ProbesHXB · Traditional | 10/31/1980SE |
| K792100 | Grasping Forcep (W/Four Prongs)GEN · Traditional | 11/13/1979SE |
| K791052 | Endoscopic InstrumentHET · Traditional | 08/03/1979SE |
Questions and answers
When was Laser Bronchoscope cleared by the FDA?
Laser Bronchoscope (K831240) received a 510(k) decision of Substantially Equivalent on July 26, 1983, 102 days after the submission was received.
What is the product code of K831240?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.