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FDA 510(k)

SURGICAL STAPLE MARKER

K-Number: K950006 · 1995-03-15

ApplicantBiopsys Medical, Inc.
Decision Date1995-03-15
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL STAPLE MARKER 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 1995-03-15 under 510(k) number K950006. 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?

SURGICAL STAPLE MARKER is a medical device that received FDA 510(k) clearance on 1995-03-15. The listed applicant is Biopsys Medical, Inc.. The 510(k) number is K950006.

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

SURGICAL STAPLE MARKER received FDA 510(k) clearance on 1995-03-15, under 510(k) number K950006.

Who is the listed applicant for SURGICAL STAPLE MARKER?

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?

The FDA product code for SURGICAL STAPLE MARKER 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)K963015SURGICAL STAPLE MARKER DEVICE (MODIFY)K960019RETRACTOR ARM CLAMPK953880BIOPSY NEEDLEK953962FORCEPS

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Related Devices (Code: GDW)

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.

K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)Ethicon Endo-Surgery, LLCK253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter ReloadsCovidien (Part of Medtronic)K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)Ethicon Endo-Surgery, LLCK250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)Ethicon Endo-Surgery, LLCK243276ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)Ethicon Endo-Surgery, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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