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FDA 510(k)

ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL

K-Number: K081129 · 2008-07-28

ApplicantSurgrx, Inc.
Decision Date2008-07-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL is the device name listed in this FDA 510(k) record. The listed applicant is Surgrx, Inc.. It received FDA 510(k) clearance on 2008-07-28 under 510(k) number K081129. 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 POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL?

ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL is a medical device that received FDA 510(k) clearance on 2008-07-28. The listed applicant is Surgrx, Inc.. The 510(k) number is K081129.

When did ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL receive FDA 510(k) clearance?

ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL received FDA 510(k) clearance on 2008-07-28, under 510(k) number K081129.

Who is the listed applicant for ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL?

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 POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL?

The FDA product code for ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL is GEI.

Related Clinical Trials

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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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.

K072493ENSEAL TISSUE SEALING DEVICEK072177ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEMK071728MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICEK070896ENSEAL PTC TISSUE SEALING DEVICEK070165ENSEAL PTC TRIOK063097ENSEAL 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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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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