W.O.M. World of Medicine AG: FDA clearances and approvals
W.O.M. World of Medicine AG has 15 FDA 510(k) clearances (first 2002, latest 2013), across 6 product codes in 4 review panels. Median 510(k) review time: 93 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 147 |
| 2013 | 1 | 120 |
| 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 |
|---|---|---|---|
| HIG | Insufflator, Hysteroscopic | 4 | 4 |
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
| HIF | Insufflator, Laparoscopic | 3 | 3 |
| HRX | Arthroscope | 3 | 3 |
| EXY | Uroflowmeter | 1 | 1 |
| LJH | System, Irrigation, Urological | 1 | 1 |
Review panels
- Obstetrics and Gynecology (7)
- Orthopedic (3)
- General and Plastic Surgery (3)
- Gastroenterology and Urology (2)
Most recent W.O.M. World of Medicine AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123732 | HYSTEROSCOPY PUMP HM6 | HIG | 2013-04-04 | 120 |
| K112642 | AQUILEX FLUID CONTROL SYSTEM H112 | HIG | 2012-02-06 | 147 |
| K063367 | 45L CORE INSUFFLATOR, MODEL F114 | HIF | 2007-05-23 | 197 |
| K062380 | FLOSIMPLE ARTHROSCOPY PUMP A120 | HRX | 2006-12-14 | 121 |
| K060723 | 40 L HIGH FLOW INSUFFLATOR F113 | HIF | 2006-05-25 | 69 |
| K042457 | URO PRO | LJH | 2004-10-25 | 45 |
| K030837 | 40 L HIGH FLOW INSUFFLATOR F108 | HIF | 2004-02-05 | 325 |
| K033927 | ARTHOSCOPY PUMP A115 | HRX | 2004-01-15 | 28 |
| K032023 | W.O.M. LASER U100PLUS | GEX | 2003-10-01 | 93 |
| K022721 | UROPOWER | EXY | 2003-08-26 | 375 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named W.O.M. World of Medicine AG.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does W.O.M. World of Medicine AG have?
W.O.M. World of Medicine AG has 15 FDA 510(k) clearances (first 2002, latest 2013), across 6 product codes in 4 review panels.
How long does FDA take to clear W.O.M. World of Medicine AG's 510(k)s?
The median time from FDA receipt to decision across W.O.M. World of Medicine AG's cleared 510(k)s is 93 days.
What devices does W.O.M. World of Medicine AG make?
Its most frequent FDA product codes are HIG (Insufflator, Hysteroscopic, 4); GEX (Powered Laser Surgical Instrument, 3); HIF (Insufflator, Laparoscopic, 3).
Has W.O.M. World of Medicine AG had device recalls?
openFDA lists no recalls under a recalling firm name matching W.O.M. World of Medicine AG. Related entities may recall under other names.
Next steps
- See all 15 W.O.M. World of Medicine AG clearances with predicates and recalls
- Run predicate analysis for product code HIG, W.O.M. World of Medicine AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.