510(k) Report

FDA applicant

Epitek, Inc.

Bloomington, MN3 decisions2008–20080 recalls

FDA records 3 decisions for Epitek, Inc. (Bloomington, MN) in 2008: 3 510(k) clearances. Most are in product codes ODC (Endoscope Channel Accessory) and GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). Its devices cite 4 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

3in 2008

2008: 3
2008high 3 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Epitek, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Epitek, Inc.’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?

  • ODCEndoscope Channel Accessory1decision
  • GATSuture, Nonabsorbable, Synthetic, Polyethylene1decision
  • FBOCystourethroscope1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K080780Anchorage Scope, Model 000003Epitek, Inc. · 2008
  • K073507Anchorage Access KitEpitek, Inc. · 2008
  • K073096Anchorage Closure DeviceEpitek, Inc. · 2008

All 3 as Epitek, Inc. →