FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ICAN CYLINDRICAL SPONGES
K Number: K914086
·
Decision Oct 9, 1991
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
25
Applicant Total
30
Review Days
28
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Basic Information
- Device Name
- ICAN CYLINDRICAL SPONGES
- K Number
- K914086
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Icn Pharmaceuticals, Inc.
- Date Received
- September 11, 1991
- Decision Date
- October 9, 1991
- Product Code
- GDX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GDX | Scalpel, One-Piece | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDX), ordered by most recent decision date.
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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 |
| K914530 | ICAN GT DRAINAGE BAG | Dec 18, 1991 | Substantially Equivalent |
| K914082 | SUAN FLAT DISSECTOR SPONGES | Nov 27, 1991 | Substantially Equivalent |
| K914083 | ICAN K DISSECTOR 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 |