Henke Sass Wolf of America, Inc.
Dudley, MA, US
HENKE SASS WOLF OF AMERICA, INC. appears in FDA device records in Dudley, MA. FDA records list 9 510(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 9 510(k) clearances for Henke Sass Wolf of America, Inc. between 1994 and 2008. The busiest year on record is 1998, with 2. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2005 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | HRX | Substantially Equivalent | |
| K050163 | HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE | GCJ | Substantially Equivalent | |
| K030572 | HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE | EOB | Substantially Equivalent | |
| K013611 | HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE | GCJ | Substantially Equivalent | |
| K991563 | CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C | HIH | Substantially Equivalent | |
| K983067 | FINE-JECT | FMI | Substantially Equivalent | |
| K981751 | SINUSCOPE AND ACCESSORIES | EOB | Substantially Equivalent | |
| K962075 | HSW GMBH ARTHROSCOPE | HRX | Substantially Equivalent | |
| K941541 | HSV LAPAROSCOPY SET | GCJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1222997 | 1000120548 | HENKE SASS WOLF OF AMERICA, INC. | 135 Schofield Ave, DUDLEY, MA 01571 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