Model 8800 Bipolar Coagulation Therapeutic System
FDA 510(k) K892895 · Everest Medical Corp.
510(k) numberK892895
Submission
- Device name
- Model 8800 Bipolar Coagulation Therapeutic System
- Applicant
- Everest Medical Corp.
Brooklyn Center, MN, US - Received
- April 25, 1989
- Decision date
- September 25, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K003060 | Plasmakinetic GeneratorGEI · Special | 10/31/2000SE |
| K000496 | Evershears Bipolar ScissorsGEI · Traditional | 04/24/2000SE |
| K993412 | Bitx ProbesGEI · Traditional | 03/31/2000SE |
| K994336 | Bitx ProbesGEI · Traditional | 02/08/2000SE |
| K971565 | Bicoag Coagulating ForcepsHIN · Traditional | 03/12/1998SE |
| K955001 | Evershears Scissors, Bilap Probes, Bicoag ForcepsGEI · Traditional | 12/13/1995SE |
| K945975 | Evershears(R) Scissors, Bilap(R) Probes, Bicoag(R) ForcepsGEI · Traditional | 12/21/1994SE |
| K922509 | Laparoscopic Electrosurg Device W/Irriga & AspiraGEI · Traditional | 10/01/1992SE |
| K922246 | Tubing Set W/ Irrigation & Aspiration ValvingGCJ · Traditional | 09/02/1992SE |
| K920089 | Monopolar Coagulating Polypectomy SnareKNS · Traditional | 03/31/1992SE |
Questions and answers
When was Model 8800 Bipolar Coagulation Therapeutic System cleared by the FDA?
Model 8800 Bipolar Coagulation Therapeutic System (K892895) received a 510(k) decision of Substantially Equivalent on September 25, 1989, 153 days after the submission was received.
What is the product code of K892895?
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.