FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SPONGES, LAPAROTOMY
K Number: K770446
·
Decision Jun 15, 1977
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
11
Review Days
100
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Basic Information
- Device Name
- SPONGES, LAPAROTOMY
- K Number
- K770446
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Walpak Co.
- Date Received
- March 7, 1977
- Decision Date
- June 15, 1977
- 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 Walpak Co.
| K Number | Device Name | ||
|---|---|---|---|
| K803200 | IRRIGATION SET W/BULB SYRINGE | Jan 21, 1981 | Substantially Equivalent |
| K803204 | IRRIGATION PISTON | Jan 21, 1981 | Substantially Equivalent |
| K803199 | SUTURE REMOVAL KIT | Jan 15, 1981 | Substantially Equivalent |
| K803198 | IRRIGATION SET W/PISTON SYRINGE | Jan 15, 1981 | Substantially Equivalent |
| K803201 | LEMON GLYCERINE SWABS | Dec 17, 1980 | Unknown |
| K802083 | CATHETER INSERTION TRAY | Sep 16, 1980 | Substantially Equivalent |
| K791598 | CLOSED SYSTEM FOLEY CATHERIZATION PROCED | Nov 16, 1979 | Substantially Equivalent |
| K780123 | CATHETERIZATION PROCEDURE TRAY | Feb 21, 1978 | Substantially Equivalent |
| K780124 | CATHETERIZATION PROCED. TRAY, URETHRAL | Feb 21, 1978 | Substantially Equivalent |
| K760560 | CATH CARE KIT | Nov 12, 1976 | Substantially Equivalent |