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FDA 510(k)

SELECTOR

K-Number: K925129 · 1993-04-23

ApplicantSpembly Medical , Ltd.
Decision Date1993-04-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SELECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Spembly Medical , Ltd.. It received FDA 510(k) clearance on 1993-04-23 under 510(k) number K925129. 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 SELECTOR?

SELECTOR is a medical device that received FDA 510(k) clearance on 1993-04-23. The listed applicant is Spembly Medical , Ltd.. The 510(k) number is K925129.

When did SELECTOR receive FDA 510(k) clearance?

SELECTOR received FDA 510(k) clearance on 1993-04-23, under 510(k) number K925129.

Who is the listed applicant for SELECTOR?

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

What is the FDA product code for SELECTOR?

The FDA product code for SELECTOR is GCJ.

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Other records listing Spembly Medical , Ltd. 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.

K903303SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBESK901974SELECTOR ULTRASONIC SURGICAL ASPIRATORK882568130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAYK882963SPEMBLY MEDICAL 142 CRYO UNITK882962SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)K874367VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF

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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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