FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
INVOTEC CLEAN PAD
K Number: K973580
·
Decision Dec 10, 1997
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
16
Review Days
82
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Basic Information
- Device Name
- INVOTEC CLEAN PAD
- K Number
- K973580
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Invotec International, Inc.
- Date Received
- September 19, 1997
- Decision Date
- December 10, 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 Invotec International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122040 | INVOTEC LARYNGEAL ELECTRODE | Oct 31, 2013 | Substantially Equivalent |
| K080740 | CLEARVIEW ENDOSCOPE COVER | Dec 31, 2008 | Substantially Equivalent |
| K030492 | TITANIUM OSSICULAR REPLACMENT SYSTEM | Mar 3, 2003 | Substantially Equivalent |
| K973578 | INVOTEC EAR TAMPON (WICK) W/STRING | Nov 6, 1997 | Substantially Equivalent |
| K971000 | EPISTAXIS NASAL PACK | May 14, 1997 | Substantially Equivalent |
| K930114 | TRACHEOSTOMY T-TUBE | Mar 19, 1993 | Substantially Equivalent |
| K911041 | INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE | Jun 4, 1991 | Substantially Equivalent |
| K911040 | INVOTEC MICROSCOPE DRAPE | Jun 3, 1991 | Substantially Equivalent |
| K911039 | INVOTEC EAR DRAPE | May 13, 1991 | Substantially Equivalent |
| K901923 | INVOTEC POLY-MESH MANDIBULAR TRAY | Oct 31, 1990 | Substantially Equivalent |