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FDA 510(k)

TROTEX II SCREW NEEDLE BIOPSY INSTR. SET

K-Number: K792316 · 1979-12-18

ApplicantUrsus Konsult AB
Decision Date1979-12-18
Product CodeGEE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TROTEX II SCREW NEEDLE BIOPSY INSTR. SET is the device name listed in this FDA 510(k) record. The listed applicant is Ursus Konsult AB. It received FDA 510(k) clearance on 1979-12-18 under 510(k) number K792316. The device is classified under product code GEE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROTEX II SCREW NEEDLE BIOPSY INSTR. SET?

TROTEX II SCREW NEEDLE BIOPSY INSTR. SET is a medical device that received FDA 510(k) clearance on 1979-12-18. The listed applicant is Ursus Konsult AB. The 510(k) number is K792316.

When did TROTEX II SCREW NEEDLE BIOPSY INSTR. SET receive FDA 510(k) clearance?

TROTEX II SCREW NEEDLE BIOPSY INSTR. SET received FDA 510(k) clearance on 1979-12-18, under 510(k) number K792316.

Who is the listed applicant for TROTEX II SCREW NEEDLE BIOPSY INSTR. SET?

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

What is the FDA product code for TROTEX II SCREW NEEDLE BIOPSY INSTR. SET?

The FDA product code for TROTEX II SCREW NEEDLE BIOPSY INSTR. SET is GEE.

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Related Devices (Code: GEE)

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.

K854003STERILE SOFT TISSUE BIOPSY NEEDLECo-Medical, Inc.K841008BIOPSY PUNCH, VARIOUSPremier Dental Products Co.K822490DEFLECTING CYTOLOGY BRUSHVan-Tec, Inc.K820259STERILE CYTOLOGY BRUSHESAmerican Endoscopy, Inc.K812694WHISK-RMedi-SpecK801304CAMLOC SYRINGE BIOPSY KITJohannah Medical Services, 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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