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FDA 510(k)

T-REX BIOPSY FORCEPS

K-Number: K973818 · 1997-12-16

ApplicantBoston Scientific Corp
Decision Date1997-12-16
Product CodeDWZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

T-REX BIOPSY FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1997-12-16 under 510(k) number K973818. The device is classified under product code DWZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-REX BIOPSY FORCEPS?

T-REX BIOPSY FORCEPS is a medical device that received FDA 510(k) clearance on 1997-12-16. The listed applicant is Boston Scientific Corp. The 510(k) number is K973818.

When did T-REX BIOPSY FORCEPS receive FDA 510(k) clearance?

T-REX BIOPSY FORCEPS received FDA 510(k) clearance on 1997-12-16, under 510(k) number K973818.

Who is the listed applicant for T-REX BIOPSY FORCEPS?

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

What is the FDA product code for T-REX BIOPSY FORCEPS?

The FDA product code for T-REX BIOPSY FORCEPS is DWZ.

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Related Devices (Code: DWZ)

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.

K252722Biopsy ForcepsFehling Instruments GmbHK170726Biopsy ForcepsFehling Instruments GmbH & Co. KGK072051NOVATOME, MODEL: SU101-50Scholten Surgical Instruments, Inc.K010473SPARROWHAWK DISPOSABLEAtc Technologies, Inc.K000409MODIFICATION TO T-REX BIOPSY FORCEPSBoston Scientific CorpK991486ULTRA-CBXMedcanica, 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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