FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
AMBU GEL, HYDROGEL BURN DRESSING
K Number: K010583
·
Decision May 25, 2001
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
33
Review Days
87
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
- AMBU GEL, HYDROGEL BURN DRESSING
- K Number
- K010583
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ambu, Inc.
- Date Received
- February 27, 2001
- Decision Date
- May 25, 2001
- 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 Ambu, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051529 | AMBU NEUROLINE GROUND | Aug 4, 2005 | Substantially Equivalent |
| K042682 | AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR | Nov 15, 2004 | Substantially Equivalent |
| K042843 | AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS | Nov 12, 2004 | Substantially Equivalent |
| K041734 | AMBU DISPOSABLE ECG ELECTRODE | Sep 22, 2004 | Substantially Equivalent |
| K040991 | AMBU DISPOSABLE PRESSURE MANOMETER | Jul 22, 2004 | Substantially Equivalent |
| K041026 | AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S | Jun 28, 2004 | Substantially Equivalent |
| K032278 | AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE | Mar 5, 2004 | Substantially Equivalent |
| K032421 | AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE | Feb 27, 2004 | Substantially Equivalent |
| K993278 | AMBU NEONATE SILICONE RESUSCITATOR | May 17, 2000 | Substantially Equivalent |
| K992902 | AMBU HAND POWER SUCTION PUMP | Oct 25, 1999 | Substantially Equivalent |