Taiwan Surgical Corporation: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Taiwan Surgical Corporation” (first 2015, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 203 days. Since 2017 the median was 203 days, against 107 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2015 | 2 | 166 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 460 |
| 2023 | 1 | 111 |
| 2024 | 0 | — |
| 2025 | 2 | 22 |
| 2026 | 3 | 294 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Taiwan Surgical Corporation took a median 203 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FZP | Clip, Implantable | 5 | 5 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Taiwan Surgical Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252535 | Inno-Switch Laparoscopic Instruments | GEI | 2026-08-25 | 378 |
| K254231 | Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips | FZP | 2026-07-20 | 203 |
| K252532 | Inno-Port Disposable Bladed Trocar | GCJ | 2026-06-02 | 294 |
| K253903 | InnoClip Disposable Clip Applier | FZP | 2025-12-22 | 17 |
| K253781 | InnoClip Clip Applier | FZP | 2025-12-22 | 26 |
| K223593 | Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar | GCJ | 2023-03-22 | 111 |
| K202994 | InnoClip Disposable Clip Applier, InnoClip Clip Applier | FZP | 2022-01-04 | 460 |
| K150259 | CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L | FZP | 2015-11-06 | 276 |
| K150253 | Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm | GCJ | 2015-04-01 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Taiwan Surgical Corporation.
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.
- Taiwan Aulisa Medical Devices Technologies, Inc. (9 510(k)s)
- Taiwan Armada Enterprise Co., Ltd. (5 510(k)s)
- Taiwan King Strong Co., Ltd. (4 510(k)s)
- Taiwan Eva Industrial Co., Inc. (3 510(k)s)
- Taiwan Main Orthopaedic Biotechnology Co., Ltd. (3 510(k)s)
- Taiwan an I Co., Ltd. (2 510(k)s)
- Taiwan Biomaterial Co., Ltd. (2 510(k)s)
- Taiwan Link Sdn Bhd (2 510(k)s)
- Taiwan Scientific Corporation (2 510(k)s)
- Taiwan an Lih Ent. Co. , Ltd. (1 510(k)s)
- Taiwan Biophotonic Corporation (1 510(k)s)
- Taiwan Comfort Champ Manufacturing Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Taiwan Surgical Corporation?
FDA lists 9 510(k) clearances under the applicant name “Taiwan Surgical Corporation” (first 2015, latest 2026), 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 Taiwan Surgical Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Taiwan Surgical Corporation is 203 days. Since 2017: 203 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Taiwan Surgical Corporation?
The most frequent FDA product codes under this applicant name are FZP (Clip, Implantable, 5); GCJ (Laparoscope, General & Plastic Surgery, 3); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 9 Taiwan Surgical Corporation clearances with predicates and recalls
- Run predicate analysis for product code FZP, Taiwan Surgical Corporation'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.