FDA product code MFJ: Device, Endoscopic Suturing
MFJ is the FDA product code for device, endoscopic suturing. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under MFJ. The average 510(k) review took 84 days (median 84).
Classification
| Field | Value |
|---|---|
| Device name | Device, Endoscopic Suturing |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MFJ clearance
Top MFJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Laparomed Corp. | 1 | 1991-03-14 |
Most recent MFJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K905722 | Laparomed Corp. | SUTURE APPLIER DEVICE | 1991-03-14 | 84 |
Recalls for MFJ devices
openFDA lists no recalls for product code MFJ.
Frequently asked questions
What is FDA product code MFJ?
MFJ is the FDA product code for device, endoscopic suturing. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel.
What device class is MFJ?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code MFJ?
Across 1 cleared submissions the average was 84 days from receipt to decision (median 84).
Which companies have the most MFJ clearances?
Laparomed Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MFJ
- Run a recall and safety report across every MFJ manufacturer
- Watch product code MFJ 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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