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FDA 510(k)

EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302

K-Number: K020031 · 2002-03-27

ApplicantNeothermia Corp.
Decision Date2002-03-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 is the device name listed in this FDA 510(k) record. The listed applicant is Neothermia Corp.. It received FDA 510(k) clearance on 2002-03-27 under 510(k) number K020031. 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 EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302?

EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 is a medical device that received FDA 510(k) clearance on 2002-03-27. The listed applicant is Neothermia Corp.. The 510(k) number is K020031.

When did EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 receive FDA 510(k) clearance?

EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 received FDA 510(k) clearance on 2002-03-27, under 510(k) number K020031.

Who is the listed applicant for EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302?

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

What is the FDA product code for EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302?

The FDA product code for EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 is GEI.

Related Clinical Trials

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Other records listing Neothermia Corp. 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.

K041347MODIFICATION TO EN-BLOC BIOPSY SYSTEMK033427MODIFICATION TO EN-BLOC BIOPSY SYSTEMK023413MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEMK022296MODIFICATION TO EN-BLOC BIOPSY SYSTEMK021577MODIFICATION TO EN-BLOC BIOPSY SYSTEMK003190EN BLOC BIOPSY SYSTEM

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Related Devices (Code: GEI)

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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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