FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENTERAL FEEDING TUBES
K Number: K881978
·
Decision Jul 13, 1988
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
14
Review Days
63
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
- ENTERAL FEEDING TUBES
- K Number
- K881978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Primrose Medical, Inc.
- Date Received
- May 11, 1988
- Decision Date
- July 13, 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 Primrose Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884714 | BILIARY DIALATOR | Sep 29, 1989 | Substantially Equivalent |
| K884715 | ACHELASIA BALLOON DIALATOR | Sep 29, 1989 | Substantially Equivalent |
| K884713 | COLONIC BALLOON DIALATORS | Sep 29, 1989 | Substantially Equivalent |
| K884711 | URETHRAL AND URETERAL BALLOON DILATATORS | Sep 29, 1989 | Substantially Equivalent |
| K884709 | ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) | Sep 8, 1989 | Substantially Equivalent |
| K884712 | ESOPHAGEAL AND PYLORIC BALLOON DIALATORS | Sep 8, 1989 | Substantially Equivalent |
| K883420 | LANCET, BLOOD | Aug 26, 1988 | Substantially Equivalent |
| K881976 | CATHETER, INTRAVASCULAR | Aug 4, 1988 | Substantially Equivalent |
| K881977 | PRESSURE INFUSOR | Jul 29, 1988 | Substantially Equivalent |
| K881975 | SET, INTRAVASCULAR | Jul 29, 1988 | Substantially Equivalent |