FDA product code MNL: Accessories, Cleaning Brushes, For Endoscope
MNL is the FDA product code for accessories, cleaning brushes, for endoscope. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under MNL, from 3 different applicants. The average 510(k) review took 51 days (median 54). FDA has posted 24 recalls for MNL devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Accessories, Cleaning Brushes, For Endoscope |
| Device class | Class I |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MNL clearance
Top MNL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Endovations | 2 | 1989-05-31 |
| Cox Medical Ent., Inc. | 1 | 1995-03-06 |
| Mill-Rose Laboratory | 1 | 1995-02-16 |
Most recent MNL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950689 | Cox Medical Ent., Inc. | UCB | 1995-03-06 | 20 |
| K946293 | Mill-Rose Laboratory | MILL-ROSE SCOPE CLEANING BRUSH | 1995-02-16 | 51 |
| K892218 | Endovations | ENDO-SPONGE | 1989-05-31 | 58 |
| K874239 | Endovations | CLEANING BRUSH | 1987-12-29 | 74 |
Recalls for MNL devices
24 product recalls in 13 recall events; 9 initiated in the last five years and 9 still open. Most recent: 2025-05-02.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 8 |
| 2019 | 3 |
| 2020 | 1 |
| 2022 | 6 |
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code MNL?
MNL is the FDA product code for accessories, cleaning brushes, for endoscope. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is MNL?
Class I, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MNL?
Across 4 cleared submissions the average was 51 days from receipt to decision (median 54).
Which companies have the most MNL clearances?
Endovations (2); Cox Medical Ent., Inc. (1); Mill-Rose Laboratory (1).
Have MNL devices been recalled?
Yes: 24 product recalls across 13 recall events; the most recent began 2025-05-02.
Next steps
- Run an FDA pathway report with predicate devices for product code MNL
- Run a recall and safety report across every MNL manufacturer
- Watch product code MNL 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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