FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
DUKAL ABD COMBINE PAD
K Number: K970457
·
Decision May 8, 1997
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
11
Review Days
91
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
- DUKAL ABD COMBINE PAD
- K Number
- K970457
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dukal Corp.
- Date Received
- February 6, 1997
- Decision Date
- May 8, 1997
- 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 Dukal Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K083320 | DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE | Mar 6, 2009 | Substantially Equivalent |
| K070407 | DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE | Mar 26, 2007 | Substantially Equivalent |
| K061864 | DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 | Sep 15, 2006 | Substantially Equivalent |
| K020726 | DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE | May 15, 2002 | Substantially Equivalent |
| K984564 | ETHYL CHLORIDE DISPENSER | Dec 2, 1999 | Substantially Equivalent |
| K970455 | DUKAL NON ADHERENT DRESSING | May 8, 1997 | Substantially Equivalent |
| K955476 | DUKAL TRANSPARENT WOUND DRESSING | Jan 18, 1996 | Substantially Equivalent for Some Indications |
| K940440 | DUKAL NON-WOVEN GAUZE | Mar 9, 1994 | Substantially Equivalent |
| K936095 | GAUZE SPONGE | Feb 2, 1994 | Substantially Equivalent |
| K931005 | DUKAL SKIN CLOSURE STRIP | Jul 14, 1993 | Substantially Equivalent |