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FDA 510(k)

TOPCUT

K-Number: K021525 · 2002-07-12

ApplicantH.S. Hospital Service S.R.L.
Decision Date2002-07-12
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TOPCUT is the device name listed in this FDA 510(k) record. The listed applicant is H.S. Hospital Service S.R.L.. It received FDA 510(k) clearance on 2002-07-12 under 510(k) number K021525. 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 TOPCUT?

TOPCUT is a medical device that received FDA 510(k) clearance on 2002-07-12. The listed applicant is H.S. Hospital Service S.R.L.. The 510(k) number is K021525.

When did TOPCUT receive FDA 510(k) clearance?

TOPCUT received FDA 510(k) clearance on 2002-07-12, under 510(k) number K021525.

Who is the listed applicant for TOPCUT?

The FDA 510(k) record lists H.S. Hospital Service S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOPCUT?

The FDA product code for TOPCUT 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 H.S. Hospital Service S.R.L. 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.

K020987BMN I TYPE MARROW ASPIRATION NEEDLEK013692TRAPSYSTEM SETK002947BIOMOL ASPIRATION BIOPSY NEEDLEK002944PRECISA BIOPSY NEEDLEK002946SILENT BIOPSY NEEDLE

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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