FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STOMACH TUBE LEVIN TUBE
K Number: K831974
·
Decision Jul 18, 1983
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
238
Review Days
28
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
- STOMACH TUBE LEVIN TUBE
- K Number
- K831974
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medline Industries, Inc.
- Date Received
- June 20, 1983
- Decision Date
- July 18, 1983
- 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 Medline Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN210049 | Medline ART Skin Harvesting System | Mar 27, 2024 | Unknown |
| K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) | Oct 26, 2023 | Substantially Equivalent |
| K223100 | Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) | Jun 27, 2023 | Substantially Equivalent |
| K222665 | Medline UNITE® Ankle Fusion Plating System | Jan 25, 2023 | Substantially Equivalent |
| K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe | Dec 9, 2022 | Substantially Equivalent |
| K212911 | Konig Mogen Clamp | Nov 18, 2022 | Substantially Equivalent |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Oct 25, 2022 | Substantially Equivalent |
| K213481 | Medline General Surgery Tray | May 24, 2022 | Substantially Equivalent |
| K212093 | Medline Universal Grounding Pad | Jan 14, 2022 | Substantially Equivalent |
| K213068 | Medline Smoke Evacuation Shroud | Jan 3, 2022 | Substantially Equivalent |