Data / Medical devices / United States / Acuderm, Inc.
Acuderm, Inc.: FDA-registered device maker in Fort Lauderdale, FL, United States, 4 510(k) clearances
Acuderm, Inc. is registered with the FDA (registration 1035236) in Fort Lauderdale, FL, United States. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 9, 1994. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1035236
- Address
- 6555 Powerline Road Suite 114, Fort Lauderdale, FL, United States, 33309
- Owner or operator
- ACUDERM, INC. (1035236)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- September 3, 1996
- Registered through
- 2027
- Brand names listed
- ACU-DISPO-CURETTE, ACU-EVAC, ACU-GUARD Non-Latex / Sterile Sleeve, ACU-MICRO-NEEDLE, ACU-NEEDLE, ACU-PUNCH KIT, Acu-Punch, Scissors
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Exhaust, Surgical | FYD | 2 | Manufacturer | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Manufacturer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 9, 1994 | K930043 | ACU-EVAC | FYD | Substantially Equivalent | Acuderm, Inc. | accessdata.fda.gov |
| January 27, 1992 | K915000 | ACU-GUARD | GEX | Substantially Equivalent | Acuderm, Inc. | accessdata.fda.gov |
| April 11, 1989 | K891334 | ACU-CURETTE | FZS | Substantially Equivalent | Acuderm, Inc. | accessdata.fda.gov |
| November 23, 1987 | K874024 | ACU-MICRO-NEEDLE | FMI | Substantially Equivalent | Acuderm, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Kit, Surgical Instrument, Disposable
- All makers of Scissors, General, Surgical
- All makers of Powered Laser Surgical Instrument
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Curette, Surgical, General Use
- All makers of Punch, Surgical
Updated February 9, 1994. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.