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FDA 510(k)

BIOPSY ADAPTER #H4221BG

K-Number: K864551 · 1986-12-23

ApplicantGeneral Electric Co.
Decision Date1986-12-23
Product CodeGDF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOPSY ADAPTER #H4221BG 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 1986-12-23 under 510(k) number K864551. 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 #H4221BG?

BIOPSY ADAPTER #H4221BG is a medical device that received FDA 510(k) clearance on 1986-12-23. The listed applicant is General Electric Co.. The 510(k) number is K864551.

When did BIOPSY ADAPTER #H4221BG receive FDA 510(k) clearance?

BIOPSY ADAPTER #H4221BG received FDA 510(k) clearance on 1986-12-23, under 510(k) number K864551.

Who is the listed applicant for BIOPSY ADAPTER #H4221BG?

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 #H4221BG?

The FDA product code for BIOPSY ADAPTER #H4221BG 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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