Habib EndoHPB
FDA 510(k) K180165 · Emcision , Ltd.
510(k) numberK180165
Submission
- Device name
- Habib EndoHPB
- Applicant
- Emcision , Ltd.
London, GB - Received
- January 22, 2018
- Decision date
- March 20, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K161305 | Habib EUS RFAGEI · Traditional | 07/07/2016SE |
| K150029 | Habib EUS RFAGEI · Traditional | 06/24/2015SE |
| K083292 | Habib EndohpbKNS · Traditional | 06/10/2009SE |
| K080717 | Habib Hexablate 10GEI · Traditional | 03/27/2008SE |
| K073687 | Habib Laparoscopic HexablateGEI · Traditional | 01/09/2008SE |
| K072383 | Habib EndoblateKNS · Traditional | 11/29/2007SE |
| K072126 | Habib VesealGEI · Traditional | 10/02/2007SE |
| K071103 | Habib HexablateGEI · Traditional | 06/27/2007SE |
| K051420 | Habib 4XGEI · Traditional | 08/15/2005SE |
Questions and answers
When was Habib EndoHPB cleared by the FDA?
Habib EndoHPB (K180165) received a 510(k) decision of Substantially Equivalent on March 20, 2018, 57 days after the submission was received.
What is the product code of K180165?
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.