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FDA 510(k)

ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.

K-Number: K882549 · 1988-07-21

ApplicantAcuson Corp.
Decision Date1988-07-21
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI. is the device name listed in this FDA 510(k) record. The listed applicant is Acuson Corp.. It received FDA 510(k) clearance on 1988-07-21 under 510(k) number K882549. 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 ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.?

ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI. is a medical device that received FDA 510(k) clearance on 1988-07-21. The listed applicant is Acuson Corp.. The 510(k) number is K882549.

When did ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI. receive FDA 510(k) clearance?

ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI. received FDA 510(k) clearance on 1988-07-21, under 510(k) number K882549.

Who is the listed applicant for ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.?

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

What is the FDA product code for ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.?

The FDA product code for ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI. is FCG.

Related Clinical Trials

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.

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Other records listing Acuson Corp. 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.

K023772KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMK022896CSV12 SOFTWARE VIEWERK022567SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEMK021497CYPRESS ULTRASOUND SYSTEMK010950CYPRESS SYSTEMK0028073D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING

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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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