FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
COTOLIN DRAIN SPONGE AND DRESSING SPONGE
K Number: K894505
·
Decision Sep 15, 1989
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
15
Review Days
58
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- COTOLIN DRAIN SPONGE AND DRESSING SPONGE
- K Number
- K894505
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- James River Corp.
- Date Received
- July 19, 1989
- Decision Date
- September 15, 1989
- Product Code
- EFQ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFQ), ordered by most recent decision date.
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
FDA 510(k)
FDA Unclassified
·Unknown
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
FDA 510(k)
FDA Unclassified
·Unknown
VITOP DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
FDA 510(k)
FDA Unclassified
·Unknown
CROSSTEX NON-WOVEN SPONGES
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE, SPONGES, CAT # 11-003
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by James River Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K894147 | VISULIN TRANSPARENT ADHESIVE DRESSING | Aug 9, 1989 | Substantially Equivalent for Some Indications |
| K893939 | ISOLATION MASKS | Jul 14, 1989 | Substantially Equivalent |
| K894034 | MODIFIED LABELING OF SURGICAL GLOVES | Jul 14, 1989 | Substantially Equivalent |
| K892580 | CARETOUCH EXAMINATION GLOVES | Jul 14, 1989 | Substantially Equivalent |
| K890459 | JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES | Apr 20, 1989 | Substantially Equivalent |
| K883802 | CARETEX CENTRAL SUPPLY WRAP | Oct 21, 1988 | Substantially Equivalent |
| K884112 | CARETEX OR TOWEL | Oct 13, 1988 | Substantially Equivalent |
| K883657 | SKID RESISTANT, LONG LASTING SHOE COVERS | Sep 15, 1988 | Substantially Equivalent |
| K880431 | CARETEX SURGEON'S HOODS | Feb 24, 1988 | Substantially Equivalent |
| K880481 | CARETEX SURGEON'S CAPS | Feb 24, 1988 | Substantially Equivalent |