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FDA 510(k)

MEDSURG ULTRASOUND BIOPSY TRAY

K-Number: K854289 · 1985-11-26

ApplicantMedsurg Industries, Inc.
Decision Date1985-11-26
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDSURG ULTRASOUND BIOPSY TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medsurg Industries, Inc.. It received FDA 510(k) clearance on 1985-11-26 under 510(k) number K854289. 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 MEDSURG ULTRASOUND BIOPSY TRAY?

MEDSURG ULTRASOUND BIOPSY TRAY is a medical device that received FDA 510(k) clearance on 1985-11-26. The listed applicant is Medsurg Industries, Inc.. The 510(k) number is K854289.

When did MEDSURG ULTRASOUND BIOPSY TRAY receive FDA 510(k) clearance?

MEDSURG ULTRASOUND BIOPSY TRAY received FDA 510(k) clearance on 1985-11-26, under 510(k) number K854289.

Who is the listed applicant for MEDSURG ULTRASOUND BIOPSY TRAY?

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

What is the FDA product code for MEDSURG ULTRASOUND BIOPSY TRAY?

The FDA product code for MEDSURG ULTRASOUND BIOPSY TRAY is FCG.

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Other records listing Medsurg Industries, 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.

K920780MEDSURG INSERTION TRAYK940175MEDSURG STERILE O.R. TOWELSK934731MEDSURG STERILE IMAGING PRODUCTSK925558INFILTUBEK934971STERILE LAPAROTOMY SPONGESK920421MEDSURG MARSHMALLOW TRAY

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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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