FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GAUZE AND LAP SPONGES -STERILE & NON-STERILE
K Number: K881395
·
Decision Apr 28, 1988
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
11
Review Days
24
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Basic Information
- Device Name
- GAUZE AND LAP SPONGES -STERILE & NON-STERILE
- K Number
- K881395
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- A Plus International, Inc.
- Date Received
- April 4, 1988
- Decision Date
- April 28, 1988
- 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 A Plus International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K213001 | Procedure Mask, Surgical Mask | May 11, 2022 | Substantially Equivalent |
| K102861 | SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE) | Jan 13, 2011 | Substantially Equivalent |
| K093169 | SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) | Nov 12, 2009 | Substantially Equivalent |
| K031353 | SOLUTION FACE MASKS | Jun 19, 2003 | Substantially Equivalent |
| K882283 | BOUFFANT CAP | Jun 23, 1988 | Substantially Equivalent |
| K882281 | GOWN, ISOLATION, SURGICAL (FYC) | Jun 23, 1988 | Substantially Equivalent |
| K882284 | SURGEONS CAP | Jun 23, 1988 | Substantially Equivalent |
| K882282 | SUIT, SURGICAL | Jun 23, 1988 | Substantially Equivalent |
| K882280 | COVER, SHOE OPERATING ROOM | Jun 23, 1988 | Substantially Equivalent |
| K881396 | OPERATING ROOM TOWELS -STERILE & NON-STERILE | Apr 29, 1988 | Substantially Equivalent |