← FDA Medical Device Classifications

Wound Dressings Containing Topical Analgesics

SEJ · Unclassified · Unknown

Classification

FDA Product Code
SEJ
Device class
Unclassified
Regulation
Review panel
SU
Medical specialty
Unknown
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
6
Registered establishments
3

Source

Authoritative
FDA Device Classification database
Machine
JSON-LD · Markdown