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FDA 510(k)

DEKALB

K-Number: K944414 · 1994-09-27

ApplicantEndotec, Inc.
Decision Date1994-09-27
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEKALB is the device name listed in this FDA 510(k) record. The listed applicant is Endotec, Inc.. It received FDA 510(k) clearance on 1994-09-27 under 510(k) number K944414. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEKALB?

DEKALB is a medical device that received FDA 510(k) clearance on 1994-09-27. The listed applicant is Endotec, Inc.. The 510(k) number is K944414.

When did DEKALB receive FDA 510(k) clearance?

DEKALB received FDA 510(k) clearance on 1994-09-27, under 510(k) number K944414.

Who is the listed applicant for DEKALB?

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

What is the FDA product code for DEKALB?

The FDA product code for DEKALB is GCJ.

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Other records listing Endotec, 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.

K081400FANNING-PAPPAS MODULAR KNEE BEARINGK012702BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1K992394BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENTK982418BUECHEL-PAPPAS MODULAR SALVAGE STEMK963101B-P HEMISPHERICAL ACETABULAR COMPONENTK963100TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP

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Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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