510(k) Report

FDA applicant

B&W Tek, Inc.

Newark, DE1 decision2007–20070 recalls

FDA records 1 decision for B&W Tek, Inc. (Newark, DE) in 2007: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 2 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, general and plastic surgery panel, where it files most

How often FDA has decided B&W Tek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K062363BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NMB&W Tek, Inc. · 20074cite it

What has FDA decided for it lately?

  • K062363BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NMB&W Tek, Inc. · 2007

The one decision as B&W Tek, Inc. →