Hanarostent Lowax Colon/Rectum (NNN), Hanarostent Lowax Duodenum/Pylorus (NNN)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183616 FDA 510(k)
- FDA Product Code
- MQR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3610 FDA 510(k)
- Regulation Number
- 878.3610 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hanarostent Lowax Colon/Rectum (NNN) and Hanarostent Lowax Duodenum/Pylorus (NNN) are metallic, expandable colonic stents. These devices are indicated for the palliative treatment of colorectal, pyloric, or duodenal strictures and obstructions caused by malignant neoplasms, as well as to relieve large bowel obstruction prior to colectomy.
These devices have received FDA 510(k) clearance. They are intended for clinical use as specified by the manufacturer's indications.
Frequently asked questions
What is the primary clinical indication for the HANAROSTENT LowAx?
These stents are indicated for the palliative treatment of strictures and obstructions in the colon, rectum, pylorus, or duodenum caused by malignant neoplasms. Additionally, they are used to relieve large bowel obstructions prior to a colectomy procedure.
What type of material is used in the construction of these stents?
The HANAROSTENT LowAx series consists of metallic, expandable stents designed to provide structural support to the affected area of the gastrointestinal tract.
Has this device received regulatory authorization?
Yes, the HANAROSTENT LowAx Colon/Rectum and Duodenum/Pylorus stents have received FDA 510(k) clearance under the K183616 submission.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum ..., HANAROSTENT LowAx Colon/Rectum (NNN) (K190141) — FDA 510 (k ..., HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183616 | Class II | Active |
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Manufacturer
- Manufacturer
- M.I.Tech Co., Ltd.
Sources (1)
- FDA 510(k) K183616 24 fields · synced Oct 6, 2026