FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ETHOX LAVAGE TUBE
K Number: K860599
·
Decision Mar 11, 1986
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
22
Applicant Total
19
Review Days
20
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Basic Information
- Device Name
- ETHOX LAVAGE TUBE
- K Number
- K860599
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Ethox Corp.
- Date Received
- February 19, 1986
- Decision Date
- March 11, 1986
- Product Code
- KDH
- 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 |
|---|---|---|---|
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDH), ordered by most recent decision date.
GILTECH PLUS CONNECTING TUBE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMBIPORT FLUID LAVAGE DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TUM-E-VAC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLUSHING IRRIGATION SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Ethox Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K040286 | ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS | Mar 15, 2004 | Substantially Equivalent |
| K031195 | CUF-COVER (TM) | Oct 10, 2003 | Substantially Equivalent |
| K962850 | TUM-E-VAC | Feb 21, 1997 | Substantially Equivalent |
| K935633 | NO-MES | Sep 30, 1994 | Substantially Equivalent |
| K921946 | TUM-E-VAC BITE BLOCK | Dec 9, 1992 | Substantially Equivalent |
| K885220 | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT | Sep 25, 1989 | Unknown |
| K894927 | SURGI SQUEEZ | Sep 11, 1989 | Substantially Equivalent |
| K883977 | SURGI-CUF STERILE/NON-STERILE DISPOSABLE | Feb 10, 1989 | Substantially Equivalent |
| K844988 | ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS. | Apr 4, 1985 | Substantially Equivalent |
| K841512 | ETHOX RELIA-FLO 2001 ENTERAL FEED | May 21, 1984 | Substantially Equivalent |