SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS— 510(k) K031133
Substantially EquivalentSurgrx, Inc.
FDA 510(k) clearance K031133 for SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS, Substantially Equivalent on 2003-07-03. Applicant: Surgrx, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgrx, Inc.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
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More clearances from Surgrx, Inc.
view all- K081129 — ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL
- K072493 — ENSEAL TISSUE SEALING DEVICE
- K072177 — ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM
- K071728 — MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE
- K070896 — ENSEAL PTC TISSUE SEALING DEVICE
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.