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FDA 510(k)

BIOPSY DEVICE ACCESSORY

K-Number: K945573 · 1994-12-09

ApplicantBiopsys Medical, Inc.
Decision Date1994-12-09
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOPSY DEVICE ACCESSORY is the device name listed in this FDA 510(k) record. The listed applicant is Biopsys Medical, Inc.. It received FDA 510(k) clearance on 1994-12-09 under 510(k) number K945573. 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 BIOPSY DEVICE ACCESSORY?

BIOPSY DEVICE ACCESSORY is a medical device that received FDA 510(k) clearance on 1994-12-09. The listed applicant is Biopsys Medical, Inc.. The 510(k) number is K945573.

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

BIOPSY DEVICE ACCESSORY received FDA 510(k) clearance on 1994-12-09, under 510(k) number K945573.

Who is the listed applicant for BIOPSY DEVICE ACCESSORY?

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

What is the FDA product code for BIOPSY DEVICE ACCESSORY?

The FDA product code for BIOPSY DEVICE ACCESSORY is KNW.

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Other records listing Biopsys Medical, Inc. as applicant

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.

K970817MICROMARK CLIPK970565MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)K963015SURGICAL STAPLE MARKER DEVICE (MODIFY)K960019RETRACTOR ARM CLAMPK953880BIOPSY NEEDLEK953962FORCEPS

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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

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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