FDA Product Code
FDA Product Code MNK — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K944049 | OXYGEN MOUTHGUARD | Endovations, Inc. | 1994-10-11 | Traditional | PDF ↗ |
| K933537 | ENCOMPAS COMFORT BLOCK # 0B-10 | Encompas Unlimited, Inc. | 1994-04-08 | Traditional | PDF ↗ |
| K931044 | OXY-BLOC | Gi Supply | 1993-10-04 | Traditional | PDF ↗ |
| K924764 | OVERTUBE FOR ENDSCOPIC LIGATOR | Superior Healthcare Group, Inc. | 1993-03-15 | Traditional | PDF ↗ |
| K914978 | OXYGUARD | Stantex Pty , Ltd. | 1992-01-10 | Traditional | PDF ↗ |
| K896691 | BITE BLOCK | Endoscopix | 1990-02-12 | Traditional | PDF ↗ |
Product code MNK · Class I · Gastroenterology, Urology. Data: openFDA.