Olsen Electrosurgical, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Olsen Electrosurgical, Inc.” (first 1988, latest 1994), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| HAM | Apparatus, Electrosurgical | 5 | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| FYD | Apparatus, Exhaust, Surgical | 1 | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 | 1 |
Review panels
Most recent Olsen Electrosurgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922154 | INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION | HIB | 1994-04-21 | 714 |
| K912611 | OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE | GEI | 1992-04-15 | 308 |
| K913108 | TEFLON COATED ELECTRODES/ELECTRODES HANDLES | GEI | 1991-12-23 | 164 |
| K912612 | SMOKE/ODOR EVACUATOR #757 | FYD | 1991-11-01 | 142 |
| K885200 | 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE | GEI | 1989-01-13 | 28 |
| K885199 | #500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES | GEI | 1989-01-13 | 28 |
| K884175 | #820/821 BIPOLAR FORCEPS | HAM | 1988-10-24 | 24 |
| K884174 | MODIFIED OLSEN 755/756 SWITCHPENS | HAM | 1988-10-24 | 24 |
| K884173 | #920 DISPOSABLE TUR CABLE | HAM | 1988-10-24 | 24 |
| K884172 | MODIFIED OLSEN #770 DISPOSABLE HOLSTER | HAM | 1988-10-24 | 24 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Olsen Electrosurgical, 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.
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.
- Olsen Medical (5 510(k)s)
- Olsen Electro-Surgical Instruments, Inc. (3 510(k)s)
- Olsen Industria E Comercio S.A. (1 510(k)s)
- Olsen Indústria E Comércio S.A. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Olsen Electrosurgical, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Olsen Electrosurgical, Inc.” (first 1988, latest 1994), across 4 product codes in 3 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 Olsen Electrosurgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Olsen Electrosurgical, Inc. is 28 days.
Which FDA product codes appear under Olsen Electrosurgical, Inc.?
The most frequent FDA product codes under this applicant name are HAM (Apparatus, Electrosurgical, 5); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); FYD (Apparatus, Exhaust, Surgical, 1).
Next steps
- See all 11 Olsen Electrosurgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAM, Olsen Electrosurgical, 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.