510(k) Report

FDA applicant

Taiwan Surgical Corporation

Zhubei City, TW9 decisions2015–20260 recalls

FDA records 9 decisions for Taiwan Surgical Corporation (Zhubei City, TW) from 2015 to 2026: 9 510(k) clearances. Most are in product codes FZP (Clip, Implantable) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 203 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Taiwan Surgical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2015: 22022: 12023: 12025: 22026 (partial year): 3
2015high 3 (2026) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Taiwan Surgical Corporation by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Taiwan Surgical Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FZPClip, Implantable5decisions
  • GCJLaparoscope, General & Plastic Surgery3decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 203 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 116 days; 2 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 15 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K150259CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,LTaiwan Surgical Corporation · 20152cite it
  • K202994InnoClip Disposable Clip Applier, InnoClip Clip ApplierTaiwan Surgical Corporation · 20222cite it
  • K150253Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mmTaiwan Surgical Corporation · 20151cites it

What has FDA decided for it lately?

  • K252535Inno-Switch™ Laparoscopic InstrumentsTaiwan Surgical Corporation · 2026
  • K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical Corporation · 2026
  • K252532Inno-Port Disposable Bladed TrocarTaiwan Surgical Corporation · 2026
  • K253781InnoClip Clip ApplierTaiwan Surgical Corporation · 2025
  • K253903InnoClip Disposable Clip ApplierTaiwan Surgical Corporation · 2025
  • K223593Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical TrocarTaiwan Surgical Corporation · 2023
  • K202994InnoClip Disposable Clip Applier, InnoClip Clip ApplierTaiwan Surgical Corporation · 2022
  • K150259CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,LTaiwan Surgical Corporation · 2015

All 9 as Taiwan Surgical Corporation →