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FDA 510(k)

BIOPSY NEEDLE GUIDE ATTACHMENT

K-Number: K863797 · 1987-03-27

ApplicantElscint, Inc.
Decision Date1987-03-27
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BIOPSY NEEDLE GUIDE ATTACHMENT is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1987-03-27 under 510(k) number K863797. The device is classified under product code HGL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPSY NEEDLE GUIDE ATTACHMENT?

BIOPSY NEEDLE GUIDE ATTACHMENT is a medical device that received FDA 510(k) clearance on 1987-03-27. The listed applicant is Elscint, Inc.. The 510(k) number is K863797.

When did BIOPSY NEEDLE GUIDE ATTACHMENT receive FDA 510(k) clearance?

BIOPSY NEEDLE GUIDE ATTACHMENT received FDA 510(k) clearance on 1987-03-27, under 510(k) number K863797.

Who is the listed applicant for BIOPSY NEEDLE GUIDE ATTACHMENT?

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

What is the FDA product code for BIOPSY NEEDLE GUIDE ATTACHMENT?

The FDA product code for BIOPSY NEEDLE GUIDE ATTACHMENT is HGL.

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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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