Optus Bronchoscopes
FDA 510(k) K945268 · Optus, Inc.
510(k) numberK945268
Submission
- Device name
- Optus Bronchoscopes
- Applicant
- Optus, Inc.
Denver, CO, US - Received
- October 28, 1994
- Decision date
- December 21, 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…
Other 510(k)s with product code EOQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video…EOQ · Traditional | Flexicare Medical Limited. | 09/02/2026SE |
| 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 |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TEOQ · Traditional | Fujifilm Corporation | 06/16/2026SE |
| 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 |
|---|---|---|
| K945264 | Optus OtoscopesERA · Traditional | 02/02/1996SE |
| K953913 | Optus Arthroscope & Mini-Arthroscope AccessoriesHRX · Traditional | 01/22/1996SE |
| K945265 | Optus Hysteroscopes and Contact HysteroscopesHIH · Traditional | 09/12/1995SE |
| K945262 | Optus Cystoscopes and Pediatric CystoscopesFAJ · Traditional | 05/26/1995SE |
| K945267 | Optus Arthroscopes and Mini-ArthroscopesHRX · Traditional | 05/23/1995SE |
| K945266 | Optus Laparoscopes and Operating LaparoscopesGCJ · Traditional | 02/23/1995SE |
| K944656 | Optus Sinuscopes and AccessoriesEOB · Traditional | 01/26/1995SE |
| K945263 | Optus ThoracoscopesGCJ · Traditional | 12/13/1994SE |
| K945269 | Optus LaryngoscopesCCW · Traditional | 11/07/1994SE |
Questions and answers
When was Optus Bronchoscopes cleared by the FDA?
Optus Bronchoscopes (K945268) received a 510(k) decision of Substantially Equivalent on December 21, 1995, 419 days after the submission was received.
What is the product code of K945268?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.