510(k) Report

FDA applicant

Endovations

Camp Hill, PA38 decisions1986–19963 recalls

FDA records 38 decisions for Endovations (Camp Hill, PA) from 1986 to 1996: 38 510(k) clearances. Most are in product codes OCZ (Endoscopic Grasping/Cutting Instrument…) and FGE (Stents, Drains And Dilators For The Biliary…). 3 recalls are linked to its devices, 1 Class I.

FDA’s records also spell it “Endovations, Inc.”.

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 Endovations’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Endovations since 2007.

Recalls per year

1in 2026

2017: 12018: 12026 (partial year): 1, 1 Class I
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Endovations by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OCZEndoscopic Grasping/Cutting Instrument, Non-Powered14decisions
  • FGEStents, Drains And Dilators For The Biliary Ducts4decisions
  • FBKEndoscopic Injection Needle, Gastroenterology-Urology2decisions
  • OCXEndoscopic Irrigation/Suction System2decisions
  • KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)2decisions
  • KNTTubes, Gastrointestinal (And Accessories)2decisions

Also: MNL (2), FCF (1), GCJ (1), FDI (1), GCP (1), KNW (1).

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.

  • K874063Enteron Abdominal Paracentesis TrayEndovations · 19871cites it

What has FDA decided for it lately?

  • K955413Endovations Triple Lumen Balloon Dilatation CatheterEndovations · 1996
  • K942110Inject-SnareEndovations · 1994
  • K944049Oxygen MouthguardEndovations, Inc. · 1994
  • K934315Endovations (R) .035 Pre-Cut PapillatomeEndovations · 1994
  • K9138412 Lumen Endos Retro Cholangiopancrea Injec CathEndovations · 1991
  • K9138705MM MicroscissorsEndovations · 1991
  • K911155Oval Cup Biopsy ForcepEndovations · 1991
  • K892218Endo-SpongeEndovations · 1989

All 37 as Endovations →The one decision as Endovations, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K874063Description/REF: PARACENTESIS KIT/ASK-00376-JHHApr 21, 2026Class I
  • K874063Maximal Barrier Drape; Product Codes: ASK-00376-SUApr 11, 2018Class II
  • K874063Large Volume Abdominal Paracentesis KitOct 24, 2017Class II