MIC LOW PROFILE GASTROSTOMY TUBE
FDA 510(k) clearance K922667 · decided 1993-12-01
Clearance details
- K-number
- K922667
- Device name
- MIC LOW PROFILE GASTROSTOMY TUBE
- Applicant
- Medical Innovations Corp.
- Decision
- Unknown
- Date received
- 1992-04-13
- Decision date
- 1993-12-01
- Days to decision
- 597 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Milpitas, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile recall (Z-2422-2024) | Avanos Medical, Inc. | 2024-07-23 |