FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG
K Number: K962218
·
Decision Sep 12, 1996
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
15
Review Days
94
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
- CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG
- K Number
- K962218
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Carrington Laboratories, Inc.
- Date Received
- June 10, 1996
- Decision Date
- September 12, 1996
- Product Code
- MGQ
- 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 |
|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MGQ), ordered by most recent decision date.
HylaGuard Moisturizing Cream
FDA 510(k)
FDA Unclassified
·Unknown
HYLATOPIC EMOLLIENT FOAM
FDA 510(k)
FDA Unclassified
·Unknown
IMPRUV A.I. CREAM WOUND AND SKIN EMULSION
FDA 510(k)
FDA Unclassified
·Unknown
SILVERSITE OR CALGITROL
FDA 510(k)
FDA Unclassified
·Unknown
SILVERSEAL
FDA 510(k)
FDA Unclassified
·Unknown
TENDERWET ACTIVE
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Carrington Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K022670 | CARRAKLENZ AND ULTRAKLENZ | Oct 17, 2002 | Substantially Equivalent |
| K012126 | THE SALICEPT ORAL PATCH | Oct 3, 2001 | Substantially Equivalent |
| K983182 | ALOE THERAPY ORAL RINSE | Dec 10, 1998 | Substantially Equivalent |
| K964852 | RADIACARE ORAL WOUND RINSE | Mar 3, 1997 | Substantially Equivalent |
| K961758 | CARASYN HYDROGEL WOUND PRODUCTS | Jul 11, 1996 | Substantially Equivalent for Some Indications |
| K960428 | CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION) | Mar 21, 1996 | Substantially Equivalent for Some Indications |
| K953423 | CASRRASYN ORAL WOUND DRESSING | Oct 11, 1995 | Substantially Equivalent |
| K951417 | CARRASYN HYDROGEL WOUND DRESSING, FDG PADS, CARRAGAUZE PADS, STRIPS | May 10, 1995 | Substantially Equivalent |
| K944427 | CARRASYN FDG | Nov 29, 1994 | Substantially Equivalent for Some Indications |
| K933741 | CARRASYN ORAL WOUND DRESSING | May 4, 1994 | Substantially Equivalent for Some Indications |