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FDA 510(k)

SURGICAL STAPLE MARKER DEVICE (MODIFY)

K-Number: K963015 · 1996-10-07

ApplicantBiopsys Medical, Inc.
Decision Date1996-10-07
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL STAPLE MARKER DEVICE (MODIFY) 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 1996-10-07 under 510(k) number K963015. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL STAPLE MARKER DEVICE (MODIFY)?

SURGICAL STAPLE MARKER DEVICE (MODIFY) is a medical device that received FDA 510(k) clearance on 1996-10-07. The listed applicant is Biopsys Medical, Inc.. The 510(k) number is K963015.

When did SURGICAL STAPLE MARKER DEVICE (MODIFY) receive FDA 510(k) clearance?

SURGICAL STAPLE MARKER DEVICE (MODIFY) received FDA 510(k) clearance on 1996-10-07, under 510(k) number K963015.

Who is the listed applicant for SURGICAL STAPLE MARKER DEVICE (MODIFY)?

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 SURGICAL STAPLE MARKER DEVICE (MODIFY)?

The FDA product code for SURGICAL STAPLE MARKER DEVICE (MODIFY) is GDW.

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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)K960019RETRACTOR ARM CLAMPK953880BIOPSY NEEDLEK953962FORCEPSK951326BIOPSY DEVICE ACCESSORY

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Related Devices (Code: GDW)

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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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