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FDA 510(k)

BIOPSY ADAPTER H4222W

K-Number: K861050 · 1986-04-02

ApplicantGeneral Electric Co.
Decision Date1986-04-02
Product CodeGDF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOPSY ADAPTER H4222W is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1986-04-02 under 510(k) number K861050. The device is classified under product code GDF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPSY ADAPTER H4222W?

BIOPSY ADAPTER H4222W is a medical device that received FDA 510(k) clearance on 1986-04-02. The listed applicant is General Electric Co.. The 510(k) number is K861050.

When did BIOPSY ADAPTER H4222W receive FDA 510(k) clearance?

BIOPSY ADAPTER H4222W received FDA 510(k) clearance on 1986-04-02, under 510(k) number K861050.

Who is the listed applicant for BIOPSY ADAPTER H4222W?

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

What is the FDA product code for BIOPSY ADAPTER H4222W?

The FDA product code for BIOPSY ADAPTER H4222W is GDF.

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Other records listing General Electric Co. as applicant

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Related Devices (Code: GDF)

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.

K031173NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013Needle Tech Products, Inc.K950311GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIREGlobal Medical Products, Ltd.K950007SURGICAL INSTRUMENT GUIDEUnited States Surgical, A Division of Tyco HealthcK945124BREAST LESION LOCALIZATION NEEDLEPromex, Inc.K944942BREAST LESION LOCALIZATION NEEDLEPromedical , Ltd.K935538BAUER TEMNO COAXIAL NEEDLEBauer Medical, 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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