FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BIONECT HYDROGEL
K Number: K984413
·
Decision Feb 10, 1999
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
10
Review Days
85
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
- BIONECT HYDROGEL
- K Number
- K984413
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fidia Pharmaceutical Corp.
- Date Received
- November 17, 1998
- Decision Date
- February 10, 1999
- 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 Fidia Pharmaceutical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K984264 | MODIFICATION OF BIONECT CLEAR HYDROGEL | Feb 10, 1999 | Substantially Equivalent |
| K984266 | MODIFICATION OF BIONECT HYDROGEL SPRAY | Feb 10, 1999 | Substantially Equivalent |
| K984262 | MODIFICATION OF BIONECT HYDROGEL GAUZE PADS | Feb 10, 1999 | Substantially Equivalent |
| K984267 | MODIFICATION OF BIONECT HYDROGEL FOAM | Feb 10, 1999 | Substantially Equivalent |
| K973725 | BIONECT CLEAR HYDROGEL | Sep 22, 1998 | Substantially Equivalent |
| K973721 | BIONECT HYDROGEL GAUZE PADS | Sep 22, 1998 | Substantially Equivalent |
| K973722 | BIONECT HYDROGEL FOAM | Sep 22, 1998 | Substantially Equivalent |
| K973724 | BIONECT HYDROGEL SPRAY | Sep 22, 1998 | Substantially Equivalent |
| K963004 | BIONECT CREAM | Feb 12, 1997 | Substantially Equivalent for Some Indications |