FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LOPEZ VALVE WITH NG SUMP TUBE
K Number: K921104
·
Decision Oct 26, 1992
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
12
Applicant Total
66
Review Days
231
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
- LOPEZ VALVE WITH NG SUMP TUBE
- K Number
- K921104
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Icu Medical, Inc.
- Date Received
- March 9, 1992
- Decision Date
- October 26, 1992
- Product Code
- FEG
- 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 |
|---|---|---|---|
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FEG), ordered by most recent decision date.
14Fr Colon Decompression Set, Macon Colon Decompression Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDLINE ANTI-REFLUX VALVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEXT GENERATION SALEM SUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KNOTT NG TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Icu Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252130 | LifeShield Infusion Safety Software Suite | Apr 2, 2026 | Substantially Equivalent |
| K252006 | OTTO Disinfecting Cap | Mar 27, 2026 | Substantially Equivalent |
| K251980 | ClaveQS Bag | Mar 20, 2026 | Substantially Equivalent |
| K250616 | Clave Neutral-Displacement Needlefree Connectors | Jun 5, 2025 | Substantially Equivalent |
| K242114 | Plum Solo Precision IV Pump | Apr 2, 2025 | Substantially Equivalent |
| K242117 | LifeShield Infusion Safety Software Suite | Apr 2, 2025 | Substantially Equivalent |
| K242115 | Plum Duo Precision IV Pump | Apr 2, 2025 | Substantially Equivalent |
| K243985 | Rio Drug Reconstitution Transfer Device | Jan 22, 2025 | Substantially Equivalent |
| K223607 | Plum Duo Infusion System | Aug 24, 2023 | Substantially Equivalent |
| K223606 | LifeShield Infusion Safety Software Suite | Aug 24, 2023 | Substantially Equivalent |