Data / Medical devices / United States / Acra Cut, Inc.
Acra Cut, Inc.: FDA-registered device maker in Acton, MA, United States, 5 510(k) clearances
Acra Cut, Inc. is registered with the FDA (registration 1220724) in Acton, MA, United States. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 8, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1220724
- Address
- 989 Main ST., Acton, MA, United States, 01720
- Owner or operator
- ACRA CUT, INC. (1220724)
- Roles
- Manufacturer
- First device listed
- June 5, 2000
- Registered through
- 2026
- Brand names listed
- ACRA GUN, ACRA-CUT CLIP APPLIER, Acra Cut Cranial Blades, Acra Cut Cranial Perforators, Acra Cut Distraction Screw, Acra Cut Dura Separators, Acra Cut Scalp Clips, Acra Cut Wire Pass Drill and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applier, Surgical, Clip | GDO | 1 | Manufacturer | accessdata.fda.gov |
| Clip, Scalp | HBO | 2 | Manufacturer | accessdata.fda.gov |
| Drills, Burrs, Trephines & Accessories (Compound, Powered) | HBF | 2 | Manufacturer | accessdata.fda.gov |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Clip Removal | HBQ | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 8, 2003 | K032970 | ACRA-CUT XPRESS 120 | HBF | Substantially Equivalent | Acra Cut, Inc. | accessdata.fda.gov |
| November 18, 1994 | K944311 | ACRA-CUT | HBO | Substantially Equivalent | Acra Cut, Inc. | accessdata.fda.gov |
| September 10, 1991 | K911819 | ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED | HBE | Substantially Equivalent | Acra Cut, Inc. | accessdata.fda.gov |
| September 10, 1991 | K911812 | ACRA-CUT WIRE PASS DRILL | HBE | Substantially Equivalent | Acra Cut, Inc. | accessdata.fda.gov |
| December 29, 1983 | K833266 | ACRA-CUT | HBF | Substantially Equivalent | Acra Cut, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Surgical, Disposable
- All makers of Drills, Burrs, Trephines & Accessories (Compound, Powered)
- All makers of Instrument, Clip Removal
- All makers of Drills, Burrs, Trephines & Accessories (Simple, Powered)
- All makers of Applier, Surgical, Clip
- All makers of Clip, Scalp
Updated December 8, 2003. 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.