FDA product code MND: Ligator, Esophageal
MND is the FDA product code for ligator, esophageal. It is a Class II device, regulated under 21 CFR 876.4400 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 15 510(k) submissions under MND, from 9 different applicants. The average 510(k) review took 127 days (median 87). FDA has posted 5 recalls for MND devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Ligator, Esophageal |
| Device class | Class II |
| Regulation | 21 CFR 876.4400 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MND clearance
Top MND applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 4 | 2003-11-06 |
| Olympus America, Inc. | 3 | 2001-12-11 |
| Scandimed International | 2 | 2009-02-19 |
| Endochoice, Inc. | 1 | 2013-08-23 |
| Ethicon Endo-Surgery, Inc. | 1 | 2005-10-07 |
4 more applicants have MND clearances. See the full list in Caduvo.
Most recent MND clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132535 | Endochoice, Inc. | AUTOBAND LIGATOR | 2013-08-23 | 10 |
| K083556 | Scandimed International | MODIFICATION TO AUTO-BAND LIGATOR | 2009-02-19 | 79 |
| K081142 | Scandimed International | AUTO-BAND LIGATOR | 2008-05-16 | 24 |
| K051950 | Ethicon Endo-Surgery, Inc. | INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 | 2005-10-07 | 81 |
| K031236 | Scandimed. A.S. | AUTO-BAND LIGATOR | 2003-11-14 | 210 |
Recalls for MND devices
5 product recalls in 5 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-10-30.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2023 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MND?
MND is the FDA product code for ligator, esophageal. It is a Class II device, regulated under 21 CFR 876.4400 and reviewed by the Gastroenterology and Urology panel.
What device class is MND?
Class II, regulation 21 CFR 876.4400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MND?
Across 15 cleared submissions the average was 127 days from receipt to decision (median 87).
Which companies have the most MND clearances?
C.R. Bard, Inc. (4); Olympus America, Inc. (3); Scandimed International (2); Endochoice, Inc. (1); Ethicon Endo-Surgery, Inc. (1).
Have MND devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2025-10-30.
Next steps
- Run an FDA pathway report with predicate devices for product code MND
- Run a recall and safety report across every MND manufacturer
- Watch product code MND 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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