FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
FLUFF GAUXZE ROLL
K Number: K945019
·
Decision Dec 23, 1994
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
14
Review Days
72
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Basic Information
- Device Name
- FLUFF GAUXZE ROLL
- K Number
- K945019
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clinical Resources, Inc.
- Date Received
- October 12, 1994
- Decision Date
- December 23, 1994
- 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 Clinical Resources, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941470 | TRACHEOSTOMY CARE KIT | Feb 14, 1995 | Unknown |
| K944882 | IRRIGATION TRAY | Jan 12, 1995 | Substantially Equivalent |
| K944881 | SKIN SCRUB TRAY | Dec 27, 1994 | Unknown |
| K944879 | GAUZE SPONGES | Dec 23, 1994 | Substantially Equivalent |
| K945021 | FLUFF GAUZE SPONGE | Dec 23, 1994 | Substantially Equivalent |
| K945020 | FLUFF GAUZE SPONGE | Dec 23, 1994 | Substantially Equivalent |
| K944880 | BODILY FLUID DISPOSAL KIT | Dec 15, 1994 | Substantially Equivalent |
| K941469 | IV START KIT | May 12, 1994 | Substantially Equivalent |
| K941468 | DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY | May 12, 1994 | Substantially Equivalent |
| K941471 | CENTRAL LINE DRESSING CHANGE TRAY | May 12, 1994 | Substantially Equivalent |