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FDA 510(k)

MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE

K-Number: K840354 · 1984-03-12

ApplicantSherwood Medical Co.
Decision Date1984-03-12
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Sherwood Medical Co.. It received FDA 510(k) clearance on 1984-03-12 under 510(k) number K840354. 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 MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE?

MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE is a medical device that received FDA 510(k) clearance on 1984-03-12. The listed applicant is Sherwood Medical Co.. The 510(k) number is K840354.

When did MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE receive FDA 510(k) clearance?

MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE received FDA 510(k) clearance on 1984-03-12, under 510(k) number K840354.

Who is the listed applicant for MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE?

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

What is the FDA product code for MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE?

The FDA product code for MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE is FCG.

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Other records listing Sherwood Medical Co. 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.

K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONSK960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAK962880SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEMK960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMK960677KANGAROO JEJUNAL FEEDING SYSTEMK960632KANGAROO FEEDING TUBE PLACMENT STYLET

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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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