510(k) Report

FDA applicant

Olympus Medical Systems Copr.

Center Valley, PA1 decision2015–20153 recalls

FDA records 1 decision for Olympus Medical Systems Copr. (Center Valley, PA) in 2015: 1 510(k) clearance. All are in product code KNS (Unit, Electrosurgical, Endoscopic (With Or…). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Olympus Medical Systems Copr.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

3in 2026

2026 (partial year): 3
2015high 3 (2026) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Olympus Medical Systems Copr. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K141991Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SPOlympus Medical Systems Copr. · 20153cite it

What has FDA decided for it lately?

  • K141991Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SPOlympus Medical Systems Copr. · 20153 recalls

The one decision as Olympus Medical Systems Copr. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K141991Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Jan 7, 2026Class II
  • K141991Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Jan 7, 2026Class II
  • K141991Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Jan 7, 2026Class II

Other applicant names beginning “Olympus”

FDA records each applicant name separately; these may or may not be the same firm.

Olympus Medical Systems Corp. 190Olympus America, Inc. 149Olympus Corp. 149Olympus Optical Co., Ltd. 48Olympus Winter & Ibe GmbH 43Olympus Surgical Technologies America 14Olympus Diagnostica GmbH 4Olympus Life Science Research Europa GmbH (Europa) 3Olympus Terumo Biomaterials Corporation 3Olympus Life & Material Science Europa GmbH (Irish 3Olympus Corp of America 2Olympus Opto-Electronics Co., Ltd. 2