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FDA 510(k)

MAMMARY SIZER

K-Number: K961356 · 1996-09-23

ApplicantGeneral Surgical Innovations
Decision Date1996-09-23
Product CodeMRD
DecisionSubstantially Equivalent for Some Indications

Device Summary

MAMMARY SIZER is the device name listed in this FDA 510(k) record. The listed applicant is General Surgical Innovations. It received FDA 510(k) clearance on 1996-09-23 under 510(k) number K961356. The device is classified under product code MRD. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MAMMARY SIZER?

MAMMARY SIZER is a medical device that received FDA 510(k) clearance on 1996-09-23. The listed applicant is General Surgical Innovations. The 510(k) number is K961356.

When did MAMMARY SIZER receive FDA 510(k) clearance?

MAMMARY SIZER received FDA 510(k) clearance on 1996-09-23, under 510(k) number K961356.

Who is the listed applicant for MAMMARY SIZER?

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

What is the FDA product code for MAMMARY SIZER?

The FDA product code for MAMMARY SIZER is MRD.

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Other records listing General Surgical Innovations 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.

K983318FIXATION SYSTEMK973046SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAKK972109SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDERK970201GSI CANNULA WITH INTRODUCERK962702SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULAK952278THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA

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Related Devices (Code: MRD)

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.

K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLCK241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLCK203229NATRELLE INSPIRA Single Use Sizers for Gel ImplantsAllerganK200706Sientra OPUS Silicone Gel Breast Implant SizerSientra, Inc.K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMotiva USA, LLCK131853MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZERMentor Worldwide, LLC

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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