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FDA 510(k)

RADI-BIOPSY DEVICE

K-Number: K850605 · 1985-08-09

ApplicantRadiplast AB
Decision Date1985-08-09
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RADI-BIOPSY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Radiplast AB. It received FDA 510(k) clearance on 1985-08-09 under 510(k) number K850605. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADI-BIOPSY DEVICE?

RADI-BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 1985-08-09. The listed applicant is Radiplast AB. The 510(k) number is K850605.

When did RADI-BIOPSY DEVICE receive FDA 510(k) clearance?

RADI-BIOPSY DEVICE received FDA 510(k) clearance on 1985-08-09, under 510(k) number K850605.

Who is the listed applicant for RADI-BIOPSY DEVICE?

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

What is the FDA product code for RADI-BIOPSY DEVICE?

The FDA product code for RADI-BIOPSY DEVICE is KNW.

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Related Devices (Code: KNW)

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.

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Official Source

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