510(k) Report

FDA applicant

Stryker Ent

Plymouth, MN3 decisions2020–20200 recalls

FDA records 3 decisions for Stryker Ent (Plymouth, MN) in 2020: 3 510(k) clearances. Most are in product codes PGW (Ear, Nose, And Throat Stereotaxic Instrument) and LRC (Instrument, Ent Manual Surgical). Since 2016 its 510(k)s took a median of 101 days from receipt to decision, against 100 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 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, neurology panel, where it files most

How often FDA has decided Stryker Ent’s devices, and how often a recall has named them.

FDA decisions per year

3in 2020

2020: 3
2020high 3 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Stryker Ent by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • PGWEar, Nose, And Throat Stereotaxic Instrument2decisions
  • LRCInstrument, Ent Manual Surgical1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 101 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 100 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K193118TGS Guidewire and updated Scopis SoftwareStryker Ent · 20201cites it

What has FDA decided for it lately?

  • K201398SINUSPRIME Dilation SystemStryker Ent · 2020
  • K193118TGS Guidewire and updated Scopis SoftwareStryker Ent · 2020
  • K193502TGS Universal Headrest with Mounting ArmStryker Ent · 2020

All 3 as Stryker Ent →

Other applicant names beginning “Stryker”

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

Stryker Corp. 354Stryker Endoscopy 103Stryker Instruments 77Stryker Spine 76Stryker Leibinger GmbH & Co KG 36Stryker Neurovascular 36Stryker Sustainability Solutions 34Stryker Trauma AG 32Stryker Orthopaedics 24Stryker Medical 14Stryker Instruments, Instruments Div. 6Stryker Corporate 6