Micro-Shev , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Micro-Shev , Ltd.” (first 1979, latest 1991), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 130 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | 3 | 3 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| JXE | Device, Nerve Conduction Velocity Measurement | 1 | 1 |
Review panels
- Neurology (5)
Most recent Micro-Shev , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913785 | CORONET 100 | GWJ | 1991-12-31 | 130 |
| K900378 | EMG OPTION FOR MICROSHEV 4000 | JXE | 1990-04-10 | 74 |
| K894608 | MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM | GWF | 1989-12-29 | 164 |
| K874193 | MICROSHEV MODEL 2000 | GWJ | 1988-03-21 | 159 |
| K792085 | C-ERA-100 COMPUTERIZED ELECTRIC RESPON | GWJ | 1979-10-30 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Micro-Shev , Ltd..
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.
- Micro Media Laboratories (52 510(k)s)
- Micro Therapeutics, Inc. (51 510(k)s)
- Micro-Tech (Nanjing) Co., Ltd. (41 510(k)s)
- Micro-Aire Surgical Instruments, Inc. (40 510(k)s)
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (32 510(k)s)
- Micro Surgical Instruments Corp. (15 510(k)s)
- Micro Motors, Inc. (14 510(k)s)
- Micro Detect, Inc. (11 510(k)s)
- Micro-Mega Societe Anonyme (11 510(k)s)
- Micro-Bio-Logics (9 510(k)s)
- Micro Direct, Inc. (9 510(k)s)
- Micro Current Technology, Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Micro-Shev , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Micro-Shev , Ltd.” (first 1979, latest 1991), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Micro-Shev , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micro-Shev , Ltd. is 130 days.
Which FDA product codes appear under Micro-Shev , Ltd.?
The most frequent FDA product codes under this applicant name are GWJ (Stimulator, Auditory, Evoked Response, 3); GWF (Stimulator, Electrical, Evoked Response, 1); JXE (Device, Nerve Conduction Velocity Measurement, 1).
Next steps
- See all 5 Micro-Shev , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GWJ, Micro-Shev , Ltd.'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.