Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380
FDA 510(k) K060323 · Boston Scientific Corporation
510(k) numberK060323
Submission
- Device name
- Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- February 9, 2006
- Decision date
- May 12, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQR – Stent, Colonic, Metallic, Expandable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3610
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code MQR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent…MQR · Special | Boston Scientific Corporation | 03/08/2024SE |
| K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery SystemMQR · Traditional | Boston Scientific Corporation | 08/17/2020SE |
| K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal…MQR · Traditional | Boston Scientific Corporation | 04/17/2020SE |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN)MQR · Special | M.I.Tech Co., Ltd. | 03/07/2019SE |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)MQR · Traditional | M.I.Tech Co., Ltd. | 01/10/2019SE |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)MQR · Traditional | M.I.Tech Co., Ltd. | 11/02/2018SE |
| K113510 | Evolution Colonic Stent SystemMQR · Traditional | Cook Ireland, Ltd. | 05/17/2012SE |
| K061877 | Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemMQR · Traditional | Boston Scientific Corp | 09/15/2006SE |
| K042065 | Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemMQR · Traditional | Boston Scientific Corp | 09/30/2004SE |
| K030769 | Ultraflex Precision Colonic StentMQR · Traditional | Boston Scientific Corp | 07/14/2003SE |
More from Boston Scientific Corp
| 510(k) | Device | Decision |
|---|---|---|
| K262151 | SpaceOAR Flex SystemOVB · Traditional | 09/11/2026SE |
| K262460 | Rezum SystemKNS · Traditional | 09/03/2026SE |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional | 08/26/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | 08/21/2026SE |
| K262406 | EluPro Antibiotic-Eluting BioEnvelopeFTM · Special | 08/12/2026SE |
| K261915 | Navigator Flex Ureteral Access Sheath SetFED · Traditional | 08/04/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | 07/24/2026SE |
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special | 07/24/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | 07/24/2026SE |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special | 07/10/2026SE |
Questions and answers
When was Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380 cleared by the FDA?
Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380 (K060323) received a 510(k) decision of Substantially Equivalent on May 12, 2006, 92 days after the submission was received.
What is the product code of K060323?
The FDA product code is MQR – Stent, Colonic, Metallic, Expandable, a Class II (moderate risk) device regulated under 21 CFR 878.3610.