FDA product code MNK: Endoscopic Bite Block
MNK is the FDA product code for endoscopic bite block. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 6 510(k) submissions under MNK, from 6 different applicants. The average 510(k) review took 141 days (median 124).
Definition
To prevent patient from biting down in order to protect fragile endoscope equipment, patient's teeth and gums, and endscopist's fingers when inserting endoscope orally.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Bite Block |
| 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 MNK clearance
Top MNK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Endovations, Inc. | 1 | 1994-10-11 |
| Encompas Unlimited, Inc. | 1 | 1994-04-08 |
| Gi Supply | 1 | 1993-10-04 |
| Superior Healthcare Group, Inc. | 1 | 1993-03-15 |
| Stantex Pty , Ltd. | 1 | 1992-01-10 |
1 more applicants have MNK clearances. See the full list in Caduvo.
Most recent MNK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944049 | Endovations, Inc. | OXYGEN MOUTHGUARD | 1994-10-11 | 54 |
| K933537 | Encompas Unlimited, Inc. | ENCOMPAS COMFORT BLOCK # 0B-10 | 1994-04-08 | 261 |
| K931044 | Gi Supply | OXY-BLOC | 1993-10-04 | 217 |
| K924764 | Superior Healthcare Group, Inc. | OVERTUBE FOR ENDSCOPIC LIGATOR | 1993-03-15 | 173 |
| K914978 | Stantex Pty , Ltd. | OXYGUARD | 1992-01-10 | 65 |
Recalls for MNK devices
openFDA lists no recalls for product code MNK.
Frequently asked questions
What is FDA product code MNK?
MNK is the FDA product code for endoscopic bite block. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is MNK?
Class I, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MNK?
Across 6 cleared submissions the average was 141 days from receipt to decision (median 124).
Which companies have the most MNK clearances?
Endovations, Inc. (1); Encompas Unlimited, Inc. (1); Gi Supply (1); Superior Healthcare Group, Inc. (1); Stantex Pty , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MNK
- Run a recall and safety report across every MNK manufacturer
- Watch product code MNK 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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