Unimicro Medical Systems (Shenzhen) Co., Ltd.: FDA clearances and approvals
Unimicro Medical Systems (Shenzhen) Co., Ltd. has 5 FDA 510(k) clearances (first 2014, latest 2015), across 3 product codes in 2 review panels. Median 510(k) review time: 199 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 2 | 102 |
| 2015 | 3 | 245 |
| 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 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
Review panels
Most recent Unimicro Medical Systems (Shenzhen) Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141594 | Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar | GCJ | 2015-08-10 | 423 |
| K150068 | Unimicro Veress Needle | HIF | 2015-07-31 | 199 |
| K142208 | Monopolar Laparascopic Accessories | GEI | 2015-04-13 | 245 |
| K141593 | UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH | GCJ | 2014-11-13 | 153 |
| K141592 | UNIMICRO SUCTION IRRIATION TUBING SET | GCJ | 2014-08-04 | 52 |
Recalls
openFDA lists no recalls under a recalling firm named Unimicro Medical Systems (Shenzhen) Co., Ltd..
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 Unimicro Medical Systems (Shenzhen) Co., Ltd. have?
Unimicro Medical Systems (Shenzhen) Co., Ltd. has 5 FDA 510(k) clearances (first 2014, latest 2015), across 3 product codes in 2 review panels.
How long does FDA take to clear Unimicro Medical Systems (Shenzhen) Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Unimicro Medical Systems (Shenzhen) Co., Ltd.'s cleared 510(k)s is 199 days.
What devices does Unimicro Medical Systems (Shenzhen) Co., Ltd. make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 3); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); HIF (Insufflator, Laparoscopic, 1).
Has Unimicro Medical Systems (Shenzhen) Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Unimicro Medical Systems (Shenzhen) Co., Ltd. Related entities may recall under other names.
Next steps
- See all 5 Unimicro Medical Systems (Shenzhen) Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Unimicro Medical Systems (Shenzhen) Co., Ltd.'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.