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FDA 510(k)

ENSEAL PTC TRIO

K-Number: K070165 · 2007-01-29

ApplicantSurgrx, Inc.
Decision Date2007-01-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENSEAL PTC TRIO is the device name listed in this FDA 510(k) record. The listed applicant is Surgrx, Inc.. It received FDA 510(k) clearance on 2007-01-29 under 510(k) number K070165. 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 ENSEAL PTC TRIO?

ENSEAL PTC TRIO is a medical device that received FDA 510(k) clearance on 2007-01-29. The listed applicant is Surgrx, Inc.. The 510(k) number is K070165.

When did ENSEAL PTC TRIO receive FDA 510(k) clearance?

ENSEAL PTC TRIO received FDA 510(k) clearance on 2007-01-29, under 510(k) number K070165.

Who is the listed applicant for ENSEAL PTC TRIO?

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 ENSEAL PTC TRIO?

The FDA product code for ENSEAL PTC TRIO 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 DEVICEK063097ENSEAL PTC TISSUE SEALING DEVICE

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Related Devices (Code: GEI)

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.

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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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