Electrocautery Dilation Balloon, Models: EDB-0018-00, EDB-0020-00, EDB-0022-00
FDA 510(k) K082114 · Apollo Endosurgery, Inc.
510(k) numberK082114
Submission
- Device name
- Electrocautery Dilation Balloon, Models: EDB-0018-00, EDB-0020-00, EDB-0022-00
- Applicant
- Apollo Endosurgery, Inc.
Austin, TX, US - Received
- July 28, 2008
- Decision date
- December 19, 2008
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K232544 | Apollo ESG NXT System, Apollo REVISE NXT SystemQTD · Special | 09/18/2023SE |
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| K210266 | OverStitch Sx Endoscopic Suturing SystemOCW · Special | 03/02/2021SE |
| K201808 | X-Tack Endoscopic HeliX Tacking SystemPKL · Traditional | 12/15/2020SE |
| K191439 | OverStitch 2-0 Polypropylene SutureOCW · Traditional | 08/29/2019SE |
| K181141 | OverStitch Endoscopic Suturing System and AccessoriesOCW · Special | 06/27/2018SE |
| K171886 | OverStitch SX Endoscopic Suturing System (ESS)OCW · Traditional | 11/15/2017SE |
| K122270 | Overtube Endoscopic Access SystemFED · Traditional | 09/28/2012SE |
| K103155 | Sumo Access and Tissue Resection SystemODC · Traditional | 10/28/2011SE |
| K082102 | Gastric Port, Models: GAP-0016-00, GAP-0018-00, GAP-0020-00FED · Traditional | 06/14/2010SESU |
Questions and answers
When was Electrocautery Dilation Balloon, Models: EDB-0018-00, EDB-0020-00, EDB-0022-00 cleared by the FDA?
Electrocautery Dilation Balloon, Models: EDB-0018-00, EDB-0020-00, EDB-0022-00 (K082114) received a 510(k) decision of Substantially Equivalent on December 19, 2008, 144 days after the submission was received.
What is the product code of K082114?
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.