Acra Cut, Inc.
Acton, MA, US
ACRA CUT, INC. appears in FDA device records in Acton, MA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Acra Cut, Inc. between 1983 and 2003. The busiest year on record is 1991, with 4. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1989 | 1 |
| 1991 | 4 |
| 1994 | 1 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K032970 | ACRA-CUT XPRESS 120 | HBF | Substantially Equivalent | |
| K944311 | ACRA-CUT | HBO | Substantially Equivalent | |
| K911819 | ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED | HBE | Substantially Equivalent | |
| K911812 | ACRA-CUT WIRE PASS DRILL | HBE | Substantially Equivalent | |
| K910226 | DURAL DISSECTORS | HAO | Substantially Equivalent | |
| K910225 | BONE PAD REMOVER | HAO | Substantially Equivalent | |
| K892866 | AUTOMATIC CRANIAL DRILL (PERFORATOR) | HBF | Substantially Equivalent | |
| K833266 | ACRA-CUT | HBF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1220724 | 1220724 | ACRA CUT, INC. | 989 MAIN ST., ACTON, MA 01720 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain