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FDA 510(k)

BREAST STABILIZER

K-Number: K925874 · 1993-03-16

ApplicantBip USA, Inc.
Decision Date1993-03-16
Product CodeMDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BREAST STABILIZER is the device name listed in this FDA 510(k) record. The listed applicant is Bip USA, Inc.. It received FDA 510(k) clearance on 1993-03-16 under 510(k) number K925874. The device is classified under product code MDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREAST STABILIZER?

BREAST STABILIZER is a medical device that received FDA 510(k) clearance on 1993-03-16. The listed applicant is Bip USA, Inc.. The 510(k) number is K925874.

When did BREAST STABILIZER receive FDA 510(k) clearance?

BREAST STABILIZER received FDA 510(k) clearance on 1993-03-16, under 510(k) number K925874.

Who is the listed applicant for BREAST STABILIZER?

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

What is the FDA product code for BREAST STABILIZER?

The FDA product code for BREAST STABILIZER is MDM.

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Other records listing Bip USA, 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.

K024089VACUFLASH BIOPSY SYSTEMK934371BIP MULTI MODIFICATIONK934370BIP BIOPSY NEEDLE MODIFICATIONK935457LOCALIZATION WIRE OR MARKER - SURGICALK925870SPACERK925875HORIZONTAL NEEDLE GUIDE ATTACHMENT

View all 7 devices →

Related Devices (Code: MDM)

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.

K073664FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCERInjectimed, Inc.K050575FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEMFutumeds Sdn BhdK050957EUTROCHARSpecial Devices, Inc.K023173ANDREWS INTRODUCER, MODEL ASI01Andrews Surgical Innovations, Ltd.K022059MICROVASIVE PULMONARY GUIDEWIREBoston Scientific CorpK013040LIGHT SABER INTRODUCER NEEDLEMinrad, Inc.

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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