FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
K Number: K885220
·
Decision Sep 25, 1989
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
19
Review Days
279
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Basic Information
- Device Name
- PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
- K Number
- K885220
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Ethox Corp.
- Date Received
- December 20, 1988
- Decision Date
- September 25, 1989
- 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 |
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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 |
| K894927 | SURGI SQUEEZ | Sep 11, 1989 | Substantially Equivalent |
| K883977 | SURGI-CUF STERILE/NON-STERILE DISPOSABLE | Feb 10, 1989 | Substantially Equivalent |
| K860599 | ETHOX LAVAGE TUBE | Mar 11, 1986 | 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 |