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FDA 510(k)

ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM

K-Number: K050671 · 2005-04-01

ApplicantSurgrx, Inc.
Decision Date2005-04-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgrx, Inc.. It received FDA 510(k) clearance on 2005-04-01 under 510(k) number K050671. 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 VESSEL SEALING & HEMOSTASIS SYSTEM?

ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM is a medical device that received FDA 510(k) clearance on 2005-04-01. The listed applicant is Surgrx, Inc.. The 510(k) number is K050671.

When did ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM receive FDA 510(k) clearance?

ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM received FDA 510(k) clearance on 2005-04-01, under 510(k) number K050671.

Who is the listed applicant for ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM?

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 VESSEL SEALING & HEMOSTASIS SYSTEM?

The FDA product code for ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM 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)

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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