FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ICAN GT DRAINAGE BAG
K Number: K914530
·
Decision Dec 18, 1991
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
2
Applicant Total
30
Review Days
68
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Basic Information
- Device Name
- ICAN GT DRAINAGE BAG
- K Number
- K914530
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Icn Pharmaceuticals, Inc.
- Date Received
- October 11, 1991
- Decision Date
- December 18, 1991
- Product Code
- FRQ
- 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 |
|---|---|---|---|
| FRQ | Tube, Levine | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRQ), ordered by most recent decision date.
ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PEDIWET=GUAZE IMPREGNATED WITH PETROL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Icn Pharmaceuticals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K022817 | COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II | Nov 22, 2002 | Substantially Equivalent |
| K951329 | IMMUCHEM GAL-MW EA | Nov 9, 1995 | Substantially Equivalent |
| K914082 | SUAN FLAT DISSECTOR SPONGES | Nov 27, 1991 | Substantially Equivalent |
| K914083 | ICAN K DISSECTOR SPONGES | Oct 9, 1991 | Substantially Equivalent |
| K914086 | ICAN CYLINDRICAL SPONGES | Oct 9, 1991 | Substantially Equivalent |
| K914081 | ICAN COTTON RAYON BALLS | Oct 9, 1991 | Substantially Equivalent |
| K913446 | ICAN NEEDLE COUNTERS | Sep 13, 1991 | Substantially Equivalent |
| K904398 | WATER COLUMN RELIEF VALVE | Jul 9, 1991 | Substantially Equivalent |
| K770458 | BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. | May 10, 1977 | Substantially Equivalent |
| K770453 | PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE | May 3, 1977 | Substantially Equivalent |