FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACU-DERM TRANSPARENT WOUND DRESSING
K Number: K842186
·
Decision Aug 24, 1984
Classifications
1
FEI Numbers
502
Registration Numbers
502
Same Product Code
106
Applicant Total
27
Review Days
84
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
- ACU-DERM TRANSPARENT WOUND DRESSING
- K Number
- K842186
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Acme United Corp.
- Date Received
- June 1, 1984
- Decision Date
- August 24, 1984
- Product Code
- NAD
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NAD), ordered by most recent decision date.
SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
APLION TOPICAL CARE SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CENTURION SORBAVIEW OTC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DERMASTREAM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OXYBAND WOUND DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Acme United Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961323 | LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING | Jun 19, 1996 | Substantially Equivalent |
| K961452 | LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING | May 31, 1996 | Substantially Equivalent |
| K952565 | LYOFOAM EXTRA | Nov 14, 1995 | Substantially Equivalent for Some Indications |
| K895764 | MODIFIED LYOFOAM WOUND DRESSINGS | Sep 10, 1990 | Substantially Equivalent for Some Indications |
| K871740 | LYOSHEET SURGICAL SHEET FOR BURNS | Jun 9, 1987 | Substantially Equivalent |
| K864084 | LYOFOAM C ODOR-ABSORBING DRESSING | Nov 21, 1986 | Substantially Equivalent for Some Indications |
| K860085 | LYOFOAM WOUND DRESSINGS | Jun 27, 1986 | Substantially Equivalent for Some Indications |
| K860818 | ONE TIME ENTERAL FEEDING BAG | May 15, 1986 | Substantially Equivalent |
| K861015 | ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS | Apr 22, 1986 | Substantially Equivalent |
| K842064 | ACU-DERM TRANSPARENT IV DRESSING | Aug 15, 1984 | Substantially Equivalent |