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FDA 510(k)

TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018

K-Number: K002042 · 2001-02-01

ApplicantNew England Medical Corp.
Decision Date2001-02-01
Product CodeHGI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 is the device name listed in this FDA 510(k) record. The listed applicant is New England Medical Corp.. It received FDA 510(k) clearance on 2001-02-01 under 510(k) number K002042. The device is classified under product code HGI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018?

TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 is a medical device that received FDA 510(k) clearance on 2001-02-01. The listed applicant is New England Medical Corp.. The 510(k) number is K002042.

When did TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 receive FDA 510(k) clearance?

TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 received FDA 510(k) clearance on 2001-02-01, under 510(k) number K002042.

Who is the listed applicant for TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018?

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

What is the FDA product code for TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018?

The FDA product code for TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 is HGI.

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Related Devices (Code: HGI)

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.

K202915IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLCK152843Liger Medical HTU-110Liger Medical, LLCK121881DOMAIN SURGICAL SYSTEMDomain Surgical, Inc.K070877ENDOCERVICAL ELECTRODE # 2Modern Medical Equipment Mfg., Ltd.K061651FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158Apple Medical Corp.K022593THOMAS MEDICAL ELECTRODESThomas Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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