KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)
FDA 510(k) K251731 · Karl Storz SE & CO. KG
Submission
- Device name
- KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)
- Applicant
- Karl Storz SE & CO. KG
Tuttlingen, DE - Received
- June 6, 2025
- Decision date
- December 5, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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…
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 |
| K252045 | Ion Endoluminal System (IF1000)EOQ · Traditional | Intuitive Surgical, Inc. | 09/23/2025SE |
| K251894 | Himaging Bronchscope SystemEOQ · Traditional | Himaging Technology (Shanghai) Co., Ltd. | 09/23/2025SE |
More from Himaging Technology (Shanghai) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260884 | UNIDRIVE Select SystemGCJ · Traditional | 09/01/2026SE |
| K254103 | HOPKINS Telescopes for ArthroscopyHRX · Traditional | 08/26/2026SE |
| K260209 | ENDOFLATOR+; Smart Smoke EvacuationHIF · Traditional | 08/19/2026SE |
| K261706 | Endomat Select (UP220)HIG · Traditional | 07/16/2026SE |
| K252800 | KARL STORZ Endoscopic Accessories for UrologyOCZ · Traditional | 06/03/2026SE |
| K254228 | KARL STORZ Trocars with Valve SealsGCJ · Traditional | 05/11/2026SE |
| K260003 | KARL STORZ Mediastinoscopes and InstrumentsEWY · Traditional | 03/02/2026SE |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® LensOWN · Traditional | 02/26/2026SE |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040)OWN · Traditional | 02/12/2026SE |
| K250927 | KARL STORZ Cholangiography SetGCJ · Traditional | 11/22/2025SE |
Questions and answers
When was KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) cleared by the FDA?
KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) (K251731) received a 510(k) decision of Substantially Equivalent on December 5, 2025, 182 days after the submission was received.
What is the product code of K251731?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.