FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIC NEEDLE JEJUNOSTOMY TUBE KIT
K Number: K880767
·
Decision Aug 11, 1988
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
24
Review Days
167
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MIC NEEDLE JEJUNOSTOMY TUBE KIT
- K Number
- K880767
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medical Innovations Corp.
- Date Received
- February 26, 1988
- Decision Date
- August 11, 1988
- Product Code
- KNT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNT), ordered by most recent decision date.
XNY Disposable Gastric Calibration Tube
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Flexi-Seal AIR (with ENFit Connector)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
hygh-tec Drainage II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Entarik NI Feeding Tube System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORGRIP* SR NG/NI Tube Retention System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Medical Innovations Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K945612 | MIC NASOGASTRIC-GASTROJEJUNAL FEEDING TUBE | Apr 19, 1995 | Substantially Equivalent |
| K940548 | MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBE | Feb 22, 1995 | Substantially Equivalent |
| K943685 | MIC DISPOSABLE SNARE | Nov 1, 1994 | Substantially Equivalent |
| K926581 | MIC TRANSGASTRIC JEJUNAL TUBE | Sep 28, 1994 | Substantially Equivalent |
| K921652 | MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT | May 2, 1994 | Unknown |
| K921370 | MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION | May 2, 1994 | Unknown |
| K924065 | MIC PEG TUBE | Feb 17, 1994 | Unknown |
| K922667 | MIC LOW PROFILE GASTROSTOMY TUBE | Dec 1, 1993 | Unknown |
| K913320 | MIL CM-II COAGULATION MACHINE | Jun 16, 1992 | Substantially Equivalent |
| K903531 | ANTICARDIOLIPIN ANTIBODY TEST SYSTEM | Jan 25, 1991 | Substantially Equivalent |