510(k) Report

FDA applicant

Enable Medical Corp.

West Chester, OH4 decisions1997–20010 recalls

FDA records 4 decisions for Enable Medical Corp. (West Chester, OH) from 1997 to 2001: 4 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 19 predicates, 3 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 Enable Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Enable Medical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Enable Medical Corp.’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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories4decisions

Whose devices does it build on?

Its devices cite 19 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 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.

  • K972558Bipolar ScissorsEnable Medical Corp. · 19973cite it
  • K010112Bipolar Coagulation SystemEnable Medical Corp. · 20011cites it
  • K992996Enable Endoscopic Bipolar ScissorsEnable Medical Corp. · 19991cites it
  • K981219Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp. · 19981cites it

What has FDA decided for it lately?

  • K010112Bipolar Coagulation SystemEnable Medical Corp. · 2001
  • K992996Enable Endoscopic Bipolar ScissorsEnable Medical Corp. · 1999
  • K981219Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp. · 1998
  • K972558Bipolar ScissorsEnable Medical Corp. · 1997

All 4 as Enable Medical Corp. →