510(k) Report

FDA applicant

Surgrx, Inc.

Redwood City, CA12 decisions2003–20081 recall

FDA records 12 decisions for Surgrx, Inc. (Redwood City, CA) from 2003 to 2008: 12 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 28 predicates, 23 of them its own earlier devices. 1 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 Surgrx, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 52008: 1
2007high 5 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Surgrx, 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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories12decisions

Whose devices does it build on?

Its devices cite 28 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 38 times; 23 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.

  • K072177Enseal Vessel Sealing and Hemostasis SystemSurgrx, Inc. · 20076cite it
  • K031133Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller Adapter, Enseal Open and…Surgrx, Inc. · 20036cite it
  • K061526Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 20066cite it
  • K072493Enseal Tissue Sealing DeviceSurgrx, Inc. · 20074cite it
  • K063097Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 20063cite it
  • K071728Modification to: Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 20072cite it

What has FDA decided for it lately?

  • K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, Etrio-314D,-325D,-335D,-345D…Surgrx, Inc. · 2008
  • K072493Enseal Tissue Sealing DeviceSurgrx, Inc. · 2007
  • K072177Enseal Vessel Sealing and Hemostasis SystemSurgrx, Inc. · 20071 recall
  • K071728Modification to: Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2007
  • K070896Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 20071 recall
  • K070165Enseal PTC TrioSurgrx, Inc. · 20071 recall
  • K062949Enseal PTC Tissue Seating Sealing DeviceSurgrx, Inc. · 2006
  • K063097Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2006

All 12 as Surgrx, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K070165Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05Jul 9, 2010