FDA 510(k)

VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE

K-Number: K905529 · 1991-02-21

Decision Date1991-02-21

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Valleylab, Inc.. It received FDA 510(k) clearance on 1991-02-21 under 510(k) number K905529. 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 VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE?

VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE is a medical device that received FDA 510(k) clearance on 1991-02-21. The listed applicant is Valleylab, Inc.. The 510(k) number is K905529.

When did VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE receive FDA 510(k) clearance?

VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE received FDA 510(k) clearance on 1991-02-21, under 510(k) number K905529.

Who is the listed applicant for VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE?

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

What is the FDA product code for VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE?

The FDA product code for VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Valleylab, Inc. as applicant

K031011LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 K010010VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR K010013LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 K994428E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE K983743BISURE LAPAROSCOPIC BIPOLAR FORCEPS K981916LIGASURE VESSEL SEALING SYSTEM

View all 94 devices →

Related Devices (Code: GEI)

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 Instruments K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet 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.