Reusable Interface Cable 1.5 m (PRD-IFC-002)
FDA 510(k) K242061 · Creo Medical, Ltd.
510(k) numberK242061
Submission
- Device name
- Reusable Interface Cable 1.5 m (PRD-IFC-002)
- Applicant
- Creo Medical, Ltd.
Chepstow, GB - Received
- July 15, 2024
- Decision date
- August 15, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262460 | Rezum SystemKNS · Traditional | Boston Scientific | 09/03/2026SE |
| K260962 | SphincterotomeKNS · Traditional | Taewoong Medical Co., Ltd. | 05/21/2026SE |
| K252388 | Vanquish Water Vapor Ablation DeviceKNS · Traditional | Francis Medical, Inc. | 11/26/2025SE |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)KNS · Traditional | Olympus Medical Systems Corporation | 11/25/2025SE |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…KNS · Traditional | Olympus Medical Systems Corp. | 10/17/2025SE |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…KNS · Traditional | Olympus Medical Systems Corporation | 10/10/2025SE |
| K251104 | SureTome SW Sphincterotome with DomeTipKNS · Traditional | Wilson-Cook Medical | 09/29/2025SE |
| K251226 | Aqua Medical RF Vapor Ablation SystemKNS · Traditional | Aqua Medical, Inc. | 08/08/2025SE |
| K250584 | Rezum SystemKNS · Traditional | Boston Scientific Corporation | 06/11/2025SE |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001)KNS · Traditional | Creo Medical, Ltd. | 06/06/2025SE |
More from Creo Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001)KNS · Traditional | 06/06/2025SE |
| K242983 | CROMA Electrosurgical Generator (PRD-EMR-050)GEI · Special | 02/05/2025SE |
| K230328 | Speedboat Flush SB1 InstrumentKNS · Traditional | 10/31/2023SE |
| K223138 | AB1 Electrosurgical Instrument, Creo Electrosurgical SystemNEY · Traditional | 06/26/2023SE |
| K221672 | Creo Electrosurgical System with NP1 InstrumentNEY · Traditional | 02/14/2023SE |
| K200298 | ABI Instrument, Creo Electrosurgical SystemNEY · Traditional | 01/05/2021SE |
| K200003 | NP1 Instrument, Creo Electrosurgical SystemNEY · Traditional | 10/28/2020SE |
| K192905 | Creo Electrosurgical System with HS1 Hemostasis AccessoryKNS · Traditional | 03/19/2020SESK |
| K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryKNS · Traditional | 08/17/2017SE |
Questions and answers
When was Reusable Interface Cable 1.5 m (PRD-IFC-002) cleared by the FDA?
Reusable Interface Cable 1.5 m (PRD-IFC-002) (K242061) received a 510(k) decision of Substantially Equivalent on August 15, 2024, 31 days after the submission was received.
What is the product code of K242061?
The FDA product code is KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.4300.