FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE
K Number: K904801
·
Decision Jan 16, 1991
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
25
Applicant Total
33
Review Days
84
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Basic Information
- Device Name
- ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE
- K Number
- K904801
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Orion Life Systems, Inc.
- Date Received
- October 24, 1990
- Decision Date
- January 16, 1991
- Product Code
- KGC
- 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 |
|---|---|---|---|
| KGC | Tube, Gastro-Enterostomy | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Orion Life Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943835 | PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID | Jan 24, 1995 | Substantially Equivalent |
| K943834 | STERILE .9% SODIUM CHLORIDE SOLUTION | Nov 21, 1994 | Substantially Equivalent |
| K943830 | PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION | Nov 21, 1994 | Substantially Equivalent |
| K943836 | PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER | Nov 21, 1994 | Substantially Equivalent |
| K943831 | PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER | Nov 21, 1994 | Substantially Equivalent |
| K943832 | STERILE .9% SODIUM CHLORIDE FOR IRRATION | Nov 21, 1994 | Substantially Equivalent |
| K943829 | PRE-FILLED SYSRINGE W/STERILE WATER | Nov 21, 1994 | Substantially Equivalent |
| K943828 | STERILE WATER FOR IRRIGATION | Nov 21, 1994 | Substantially Equivalent |
| K943833 | STERILE WATER FOR IRRATION | Nov 1, 1994 | Substantially Equivalent |
| K923168 | DUAL PORT ENTERAL Y-ADAPTOR | Jun 17, 1994 | Substantially Equivalent |