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FDA 510(k)

NEUROSTAT, LLOYD

K-Number: K781302 · 1978-08-15

ApplicantSpembly Medical , Ltd.
Decision Date1978-08-15
Product CodeGXH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROSTAT, LLOYD 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 1978-08-15 under 510(k) number K781302. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROSTAT, LLOYD?

NEUROSTAT, LLOYD is a medical device that received FDA 510(k) clearance on 1978-08-15. The listed applicant is Spembly Medical , Ltd.. The 510(k) number is K781302.

When did NEUROSTAT, LLOYD receive FDA 510(k) clearance?

NEUROSTAT, LLOYD received FDA 510(k) clearance on 1978-08-15, under 510(k) number K781302.

Who is the listed applicant for NEUROSTAT, LLOYD?

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 NEUROSTAT, LLOYD?

The FDA product code for NEUROSTAT, LLOYD is GXH.

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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.

K925129SELECTORK903303SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBESK901974SELECTOR ULTRASONIC SURGICAL ASPIRATORK882568130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAYK882963SPEMBLY MEDICAL 142 CRYO UNITK882962SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)

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Related Devices (Code: GXH)

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.

K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.K243677iovera° SystemPacira Biosciences, Inc.K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)AtriCure, Inc.K220656iovera SystemPacira Biosciences, Inc.K211334Iovera SystemPacira Pharmaceuticals, 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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