510(k) Report

FDA applicant

Panpac Medical Corporation

Shi-Chih City, Taipei Hsien, TW12 decisions2010–20180 recalls

FDA records 12 decisions for Panpac Medical Corporation (Shi-Chih City, Taipei Hsien, TW) from 2010 to 2018: 12 510(k) clearances. Most are in product codes LKF (Cannula, Manipulator/Injector, Uterine) and HHW (Pessary, Vaginal). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2018

2010: 52011: 12013: 12014: 22016: 12017: 12018: 1
2010high 5 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Panpac Medical Corporation by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LKFCannula, Manipulator/Injector, Uterine4decisions
  • HHWPessary, Vaginal4decisions
  • HGHCannula, Suction, Uterine1decision
  • KNAInstrument, Manual, Specialized Obstetric-Gynecologic1decision
  • HDXDilator, Vaginal1decision
  • HHKCurette, Suction, Endometrial (And Accessories)1decision

Who builds on its devices?

Later devices cite its devices 9 times; 0 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.

  • K130273Panpac Vaginal DilatorsPanpac Medical Corporation · 20132cite it
  • K092981Panpac Vaginal PessaryPanpac Medical Corporation · 20102cite it
  • K092980Panpac Uterine Manipulator Injector, Model Umi 4.5Panpac Medical Corporation · 20102cite it
  • K092983Panpac HSG Catheter SetPanpac Medical Corporation · 20101cites it
  • K092982The Panpac Suction CurettePanpac Medical Corporation · 20101cites it
  • K173351Panpac Flexi Shelf PessaryPanpac Medical Corporation · 20181cites it

What has FDA decided for it lately?

  • K173351Panpac Flexi Shelf PessaryPanpac Medical Corporation · 2018
  • K161106Panpac Disposable Vacuum CurettesPanpac Medical Corporation · 2017
  • K153422Panpac Disposable Pessary Fitting SetPanpac Medical Corporation · 2016
  • K132670Panpac Inflatable Docut PessaryPanpac Medical Corporation · 2014
  • K130087Panpac Word/Bartholin CatheterPanpac Medical Corporation · 2014
  • K130273Panpac Vaginal DilatorsPanpac Medical Corporation · 2013
  • K102898Bellota Sonohysterography Catheter with Cervical Cone, Bellota Sonohysterography Catheter Without Cervical…Panpac Medical Corporation · 2011
  • K092982The Panpac Suction CurettePanpac Medical Corporation · 2010

All 12 as Panpac Medical Corporation →