Product Code: SEJ
FDA unclassified
Wound Dressings Containing Topical Analgesics
Unknown
510(k)s
6
FEI Numbers
3
Registration Numbers
3
Unique Applicants
6
Years Active
17
Basic Information
- Product Code
- SEJ
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
A solid wound dressing containing topical analgesics is used to cover and protect a wound, to absorb exudate, to maintain appropriate moisture balance within the wound, and to reduce pain. A wound dressing formulated as a gel, cream or ointment containing topical analgesics is used to maintain appropriate moisture balance within the wound and to reduce pain.
Unclassified Reason
1
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K092086 | AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 | Jul 30, 2009 | Substantially Equivalent | Amerx Health Care Corp. |
| K053476 | ALLWOUND | Jun 26, 2006 | Substantially Equivalent | At Squared, LLC |
| K020540 | REGENECARE WOUND GEL | Nov 01, 2002 | Substantially Equivalent | Mpm Medical., Inc. |
| K001023 | FREEDOM, MODEL 4660 | Sep 22, 2000 | Substantially Equivalent | Johnson & Johnson Consumer Companies, Inc. |
| K922636 | HEMO-STAT | Nov 09, 1992 | Substantially Equivalent | Mckinley-Ross Laboratories, Inc. |
| K912565 | MICRO-COLL COLLAGEN WOUND SPRAY | Jun 11, 1992 | Substantially Equivalent | Micro-Coll |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.