Henke-Sass, Wolf GmbH: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Henke-Sass, Wolf GmbH” (first 1994, latest 2018), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 192 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 | 1 | 213 |
| 2018 | 1 | 252 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Henke-Sass, Wolf GmbH took a median 232 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | 2 | 2 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FHO | Pneumoperitoneum Needle | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
Review panels
- Gastroenterology and Urology (2)
- Obstetrics and Gynecology (2)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Henke-Sass, Wolf GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173070 | HSW Resection Instruments | HIH | 2018-06-08 | 252 |
| K171336 | Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath | FAJ | 2017-12-07 | 213 |
| K101547 | HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) | FMF | 2010-11-22 | 172 |
| K952186 | HSW GMBH HYSTEROSCOPES & ACCESSORIES | HIH | 1996-02-06 | 273 |
| K943624 | ELMED PNEUMOPERITONEUM NEEDLES | FHO | 1994-08-10 | 15 |
| K941967 | HSW LAPAROSCOPE AND ACCESSORIES | GCJ | 1994-05-16 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Henke-Sass, Wolf GmbH.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Henke Sass Wolf of America, Inc. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Henke-Sass, Wolf GmbH?
FDA lists 6 510(k) clearances under the applicant name “Henke-Sass, Wolf GmbH” (first 1994, latest 2018), across 5 product codes in 4 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 GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Henke-Sass, Wolf GmbH is 192 days.
Which FDA product codes appear under Henke-Sass, Wolf GmbH?
The most frequent FDA product codes under this applicant name are HIH (Hysteroscope (And Accessories), 2); FAJ (Cystoscope And Accessories, Flexible/Rigid, 1); FHO (Pneumoperitoneum Needle, 1).
Next steps
- See all 6 Henke-Sass, Wolf GmbH clearances with predicates and recalls
- Run predicate analysis for product code HIH, Henke-Sass, Wolf GmbH'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.