FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACU-GUARD
K Number: K915000
·
Decision Jan 27, 1992
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
13
Review Days
81
Basic Information
- Device Name
- ACU-GUARD
- K Number
- K915000
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACUDERM, INC.
- Date Received
- November 7, 1991
- Decision Date
- January 27, 1992
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by ACUDERM, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K933516 | ACU-E PUNCH | Mar 24, 1994 | Substantially Equivalent |
| K933265 | ACU-DISPO-CE(TM) | Mar 7, 1994 | Substantially Equivalent |
| K933137 | ACU-SUTURE KIT | Feb 22, 1994 | Substantially Equivalent |
| K930043 | ACU-EVAC | Feb 9, 1994 | Substantially Equivalent |
| K933866 | ACU-HEMOSTATIC RING | Dec 1, 1993 | Substantially Equivalent |
| K891334 | ACU-CURETTE | Apr 11, 1989 | Substantially Equivalent |
| K874024 | ACU-MICRO-NEEDLE | Nov 23, 1987 | Substantially Equivalent |
| K854877 | ACU-SYRINGE W/WO NEEDLES | Feb 19, 1986 | Substantially Equivalent |
| K832582 | MYCOSEL AGAR | Sep 12, 1983 | Substantially Equivalent |
| K832583 | SABOURAUD DEXTROSE AGAR | Sep 12, 1983 | Substantially Equivalent |