FDA product code MQR: Stent, Colonic, Metallic, Expandable
MQR is the FDA product code for stent, colonic, metallic, expandable. It is a Class II device, regulated under 21 CFR 878.3610 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 16 510(k) submissions under MQR, 1 in the last five years, from 7 different applicants. The average 510(k) review took 154 days (median 97); 78 days on average over the last three years. FDA has posted 2 recalls for MQR devices.
Classification
| Field | Value |
|---|---|
| Device name | Stent, Colonic, Metallic, Expandable |
| Device class | Class II |
| Regulation | 21 CFR 878.3610 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MQR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 283 |
| 2019 | 2 | 26 |
| 2020 | 2 | 92 |
| 2024 | 1 | 78 |
Compare with all 510(k) review times · Search every MQR clearance
Top MQR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corp | 5 | 2006-09-15 |
| Boston Scientific Corporation | 4 | 2024-03-08 |
| M.I.Tech Co., Ltd. | 3 | 2019-03-07 |
| Cook Ireland, Ltd. | 1 | 2012-05-17 |
| Med Institute, Inc. | 1 | 2000-04-17 |
2 more applicants have MQR clearances. See the full list in Caduvo.
Most recent MQR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K234046 | Boston Scientific Corporation | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System | 2024-03-08 | 78 |
| K201159 | Boston Scientific Corporation | WallFlex Colonic Stent System with Anchor Lock Delivery System | 2020-08-17 | 109 |
| K200257 | Boston Scientific Corporation | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System | 2020-04-17 | 74 |
| K190141 | M.I.Tech Co., Ltd. | HANAROSTENT LowAx Colon/Rectum (NNN) | 2019-03-07 | 37 |
| K183616 | M.I.Tech Co., Ltd. | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | 2019-01-10 | 15 |
Recalls for MQR devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-03-07.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code MQR?
MQR is the FDA product code for stent, colonic, metallic, expandable. It is a Class II device, regulated under 21 CFR 878.3610 and reviewed by the Gastroenterology and Urology panel.
What device class is MQR?
Class II, regulation 21 CFR 878.3610. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQR?
Across 16 cleared submissions the average was 154 days from receipt to decision (median 97).
Which companies have the most MQR clearances?
Boston Scientific Corp (5); Boston Scientific Corporation (4); M.I.Tech Co., Ltd. (3); Cook Ireland, Ltd. (1); Med Institute, Inc. (1).
Have MQR devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2018-03-07.
Next steps
- Run an FDA pathway report with predicate devices for product code MQR
- Run a recall and safety report across every MQR manufacturer
- Watch product code MQR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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