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FDA 510(k)

SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS

K-Number: K031133 · 2003-07-03

ApplicantSurgrx, Inc.
Decision Date2003-07-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS is the device name listed in this FDA 510(k) record. The listed applicant is Surgrx, Inc.. It received FDA 510(k) clearance on 2003-07-03 under 510(k) number K031133. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS?

SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS is a medical device that received FDA 510(k) clearance on 2003-07-03. The listed applicant is Surgrx, Inc.. The 510(k) number is K031133.

When did SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS receive FDA 510(k) clearance?

SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS received FDA 510(k) clearance on 2003-07-03, under 510(k) number K031133.

Who is the listed applicant for SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS?

The FDA 510(k) record lists Surgrx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS?

The FDA product code for SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS is GEI.

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Other records listing Surgrx, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K081129ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSALK072493ENSEAL TISSUE SEALING DEVICEK072177ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEMK071728MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICEK070896ENSEAL PTC TISSUE SEALING DEVICEK070165ENSEAL PTC TRIO

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Related Devices (Code: GEI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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