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FDA 510(k)

STERILE SOFT TISSUE BIOPSY NEEDLE

K-Number: K854003 · 1985-10-18

ApplicantCo-Medical, Inc.
Decision Date1985-10-18
Product CodeGEE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE SOFT TISSUE BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Co-Medical, Inc.. It received FDA 510(k) clearance on 1985-10-18 under 510(k) number K854003. 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 STERILE SOFT TISSUE BIOPSY NEEDLE?

STERILE SOFT TISSUE BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1985-10-18. The listed applicant is Co-Medical, Inc.. The 510(k) number is K854003.

When did STERILE SOFT TISSUE BIOPSY NEEDLE receive FDA 510(k) clearance?

STERILE SOFT TISSUE BIOPSY NEEDLE received FDA 510(k) clearance on 1985-10-18, under 510(k) number K854003.

Who is the listed applicant for STERILE SOFT TISSUE BIOPSY NEEDLE?

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

What is the FDA product code for STERILE SOFT TISSUE BIOPSY NEEDLE?

The FDA product code for STERILE SOFT TISSUE BIOPSY NEEDLE is GEE.

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 Co-Medical, 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.

K853623CHIBA, MADAYAG, POTTS-COURNAND, SELDINGER BIOPSY N

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.

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.K792316TROTEX II SCREW NEEDLE BIOPSY INSTR. SETUrsus Konsult AB

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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