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FDA 510(k)

MONOJECT SAMPLETTE SEPARATOR TUBE

K-Number: K941291 · 1994-10-27

ApplicantSherwood Medical Co.
Decision Date1994-10-27
Product CodeGIO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MONOJECT SAMPLETTE SEPARATOR TUBE 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 1994-10-27 under 510(k) number K941291. The device is classified under product code GIO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOJECT SAMPLETTE SEPARATOR TUBE?

MONOJECT SAMPLETTE SEPARATOR TUBE is a medical device that received FDA 510(k) clearance on 1994-10-27. The listed applicant is Sherwood Medical Co.. The 510(k) number is K941291.

When did MONOJECT SAMPLETTE SEPARATOR TUBE receive FDA 510(k) clearance?

MONOJECT SAMPLETTE SEPARATOR TUBE received FDA 510(k) clearance on 1994-10-27, under 510(k) number K941291.

Who is the listed applicant for MONOJECT SAMPLETTE SEPARATOR TUBE?

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 SAMPLETTE SEPARATOR TUBE?

The FDA product code for MONOJECT SAMPLETTE SEPARATOR TUBE is GIO.

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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: GIO)

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.

K972969QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEMInnovative Medical Technologies, Inc.K894851TRU-TRAXHumagen, Inc.K885324HEMA(PRO)TEC(TION)Medical Products Search, Inc.K885138CAPILLARY TUBE, BLOOD COLLECTIONCoeur Laboratories, Inc.K884623SAFE-TEC CAPILLARY BLOOD COLLECTION TUBESafe-Tec Clinical Products, Inc.K881262CARAWAY TUBES, HEPARIN AND PLAINHelps Products, 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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