FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ISOLYSER
K Number: K940765
·
Decision Dec 19, 1994
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
21
Review Days
304
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Basic Information
- Device Name
- ISOLYSER
- K Number
- K940765
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thantex Specialties, Inc.
- Date Received
- February 18, 1994
- Decision Date
- December 19, 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 Thantex Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970547 | ISOLYSER SDS SHARPS CONTAINER | Jul 18, 1997 | Substantially Equivalent |
| K961083 | OREX SURGEON'S VEST | Aug 23, 1996 | Substantially Equivalent |
| K942200 | ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS | Aug 7, 1995 | Substantially Equivalent |
| K943626 | ISOLYSER SHARPS MANAGEMENT SYSTEM SMS | Jun 16, 1995 | Substantially Equivalent |
| K945755 | OREX(R) O.R EQUIPMENT DRAPES | May 25, 1995 | Substantially Equivalent |
| K945223 | OREX ISOLATION GOWN | Apr 25, 1995 | Substantially Equivalent |
| K944859 | OREX SURGICAL DRAPES | Feb 28, 1995 | Substantially Equivalent |
| K944827 | OREX SURGEON'S GOWN | Feb 28, 1995 | Substantially Equivalent |
| K943034 | OREX SHOE COVERS | Jan 2, 1995 | Substantially Equivalent |
| K942228 | OREX O.R. TOWEL | Dec 20, 1994 | Substantially Equivalent |