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FDA 510(k)

SURGI-VISION ESOPHAGEAL STYLET COIL

K-Number: K994436 · 2000-03-14

ApplicantSurgi-Vision, Inc.
Decision Date2000-03-14
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SURGI-VISION ESOPHAGEAL STYLET COIL is the device name listed in this FDA 510(k) record. The listed applicant is Surgi-Vision, Inc.. It received FDA 510(k) clearance on 2000-03-14 under 510(k) number K994436. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGI-VISION ESOPHAGEAL STYLET COIL?

SURGI-VISION ESOPHAGEAL STYLET COIL is a medical device that received FDA 510(k) clearance on 2000-03-14. The listed applicant is Surgi-Vision, Inc.. The 510(k) number is K994436.

When did SURGI-VISION ESOPHAGEAL STYLET COIL receive FDA 510(k) clearance?

SURGI-VISION ESOPHAGEAL STYLET COIL received FDA 510(k) clearance on 2000-03-14, under 510(k) number K994436.

Who is the listed applicant for SURGI-VISION ESOPHAGEAL STYLET COIL?

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

What is the FDA product code for SURGI-VISION ESOPHAGEAL STYLET COIL?

The FDA product code for SURGI-VISION ESOPHAGEAL STYLET COIL is MOS.

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Other records listing Surgi-Vision, 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.

K111073SURGIVISION INC. CLEARPOINT SYSTEMK020790INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COILK020495INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COILK011781INTERCEPT-URETHRAL MICROCOILK003436SURGI-VISION GUIDEWIRE COILK002916SURGI-VISION PROSTATE COIL

View all 9 devices →

Related Devices (Code: MOS)

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.

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLCK252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) 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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