Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Taiwan Surgical Corporation · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
203 daysmedian FDA review time
460 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254231 | Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inn | Taiwan Surgical Corporation | 2026-07-20 | 203 | 0 |
| K252532 | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | 2026-06-02 | 294 | 0 |
| K253781 | InnoClip Clip Applier | Taiwan Surgical Corporation | 2025-12-22 | 26 | 0 |
| K253903 | InnoClip Disposable Clip Applier | Taiwan Surgical Corporation | 2025-12-22 | 17 | 0 |
| K223593 | Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable | Taiwan Surgical Corporation | 2023-03-22 | 111 | 0 |
| K202994 | InnoClip Disposable Clip Applier, InnoClip Clip Applier | Taiwan Surgical Corporation | 2022-01-04 | 460 | 0 |
| K150259 | CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Cl | Taiwan Surgical Corporation | 2015-11-06 | 276 | 0 |
| K150253 | Disposable Suction Irrigation, 330mm, Disposable Suction Irr | Taiwan Surgical Corporation | 2015-04-01 | 57 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda