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FDA 510(k)

B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE

K-Number: K950982 · 1995-04-04

ApplicantB. Braun of America, Inc.
Decision Date1995-04-04
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun of America, Inc.. It received FDA 510(k) clearance on 1995-04-04 under 510(k) number K950982. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE?

B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE is a medical device that received FDA 510(k) clearance on 1995-04-04. The listed applicant is B. Braun of America, Inc.. The 510(k) number is K950982.

When did B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE receive FDA 510(k) clearance?

B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE received FDA 510(k) clearance on 1995-04-04, under 510(k) number K950982.

Who is the listed applicant for B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE?

The FDA 510(k) record lists B. Braun of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE?

The FDA product code for B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE is FCG.

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Other records listing B. Braun of America, 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.

K993024CELSITE IMPLANTABLE PORT WITH VALVED CATHETERK983794CHEMO MINI SPIKE PLUSK946170COMFORT-Q SUBCUTANEOUS INJECTION SETSK945850BRAUN DIACAN(R) FISTULA NEEDLESK942988FILTERED EXTENSION SETSK945752CELSITE(TM) BRACHIAL VENOUS PORT

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Related Devices (Code: FCG)

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.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.

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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