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FDA 510(k)

MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM

K-Number: K023413 · 2002-11-08

ApplicantNeothermia Corp.
Decision Date2002-11-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Neothermia Corp.. It received FDA 510(k) clearance on 2002-11-08 under 510(k) number K023413. 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 MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM?

MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 2002-11-08. The listed applicant is Neothermia Corp.. The 510(k) number is K023413.

When did MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM received FDA 510(k) clearance on 2002-11-08, under 510(k) number K023413.

Who is the listed applicant for MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM?

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 MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM?

The FDA product code for MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM is GEI.

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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 SYSTEMK022296MODIFICATION TO EN-BLOC BIOPSY SYSTEMK021577MODIFICATION TO EN-BLOC BIOPSY SYSTEMK020031EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302K003190EN BLOC BIOPSY SYSTEM

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Related Devices (Code: GEI)

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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL 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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