Henke Sass Wolf of America, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Henke Sass Wolf of America, Inc.” (first 1994, latest 2008), across 5 product codes in 5 review panels. Median 510(k) review time under this name: 58 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | 2 |
| HRX | Arthroscope | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
Review panels
- General and Plastic Surgery (3)
- Ear, Nose and Throat (2)
- Orthopedic (2)
- General Hospital (1)
- Obstetrics and Gynecology (1)
Most recent Henke Sass Wolf of America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | HRX | 2008-03-18 | 19 |
| K050163 | HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE | GCJ | 2005-03-24 | 58 |
| K030572 | HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE | EOB | 2003-04-01 | 36 |
| K013611 | HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE | GCJ | 2002-02-01 | 88 |
| K991563 | CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C | HIH | 1999-10-13 | 161 |
| K983067 | FINE-JECT | FMI | 1998-10-30 | 58 |
| K981751 | SINUSCOPE AND ACCESSORIES | EOB | 1998-08-13 | 87 |
| K962075 | HSW GMBH ARTHROSCOPE | HRX | 1997-01-17 | 234 |
| K941541 | HSV LAPAROSCOPY SET | GCJ | 1994-05-16 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Henke Sass Wolf of America, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Henke Sass Wolf of America, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Henke Sass Wolf of America, Inc.” (first 1994, latest 2008), across 5 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Henke Sass Wolf of America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Henke Sass Wolf of America, Inc. is 58 days.
Which FDA product codes appear under Henke Sass Wolf of America, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 3); EOB (Nasopharyngoscope (Flexible Or Rigid), 2); HRX (Arthroscope, 2).
Next steps
- See all 9 Henke Sass Wolf of America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Henke Sass Wolf of America, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.