Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
FDA 510(k) K143609 · Olympus Surgical Technologies America
510(k) numberK143609
Submission
- Device name
- Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
- Applicant
- Olympus Surgical Technologies America
Southborough, MA, US - Received
- December 19, 2014
- Decision date
- March 27, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
Other 510(k)s with product code FGE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260835 | ARCHIMEDES Biodegradable Stent (Medium)FGE · Traditional | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 07/27/2026SE |
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018…FGE · Traditional | Hangzhou AGS MedTech Co., Ltd. | 06/24/2026SE |
| K253832 | Dilation Balloon CatheterFGE · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 04/24/2026SE |
| K251658 | Endoflux Biliary & Pancreatic Stent SetsFGE · Traditional | Medi-Globe GmbH | 04/16/2026SE |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235)FGE · Traditional | GIE Medical | 03/13/2026SE |
| K253132 | Single use stone retrieval balloonsFGE · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 03/06/2026SE |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M StentFGE · Traditional | Taewoong Medical Co., Ltd. | 12/29/2025SESU |
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE · Traditional | Bioteque Corporation | 12/22/2025SE |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable…FGE · Traditional | Olympus Medical Systems Corporation | 10/21/2025SE |
| K251229 | EndoFixTissue Fixation SystemFGE · Traditional | Softac Medical Technologies | 08/20/2025SE |
More from Softac Medical Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Traditional | 07/24/2026SE |
| K242191 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Special | 08/23/2024SE |
| K212643 | POWERSEAL Curved Jaw Sealer and Divider, Double ActionGEI · Special | 09/27/2021SE |
| K193517 | ViziShot 2 FLEXKTI · Traditional | 03/18/2020SE |
| K183647 | SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Traditional | 08/09/2019SE |
| K190164 | CleverLock Guidewire Locking Device and Biopsy CapODC · Traditional | 04/04/2019SE |
| K181193 | PeriView FLEXKTI · Special | 07/03/2018SE |
| K171232 | PeriView FLEXKTI · Traditional | 09/21/2017SE |
| K163469 | ViziShot 2 FLEXKTI · Traditional | 04/06/2017SE |
| K132181 | Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation CatheterEZN · Traditional | 10/21/2013SE |
Questions and answers
When was Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter cleared by the FDA?
Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter (K143609) received a 510(k) decision of Substantially Equivalent on March 27, 2015, 98 days after the submission was received.
What is the product code of K143609?
The FDA product code is FGE – Stents, Drains And Dilators For The Biliary Ducts, a Class II (moderate risk) device regulated under 21 CFR 876.5010.