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FDA 510(k)

MULTIPLE BIOPSY DEVICE-MBX

K-Number: K911448 · 1991-04-16

ApplicantTriton Technology, Inc.
Decision Date1991-04-16
Product CodeFCK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MULTIPLE BIOPSY DEVICE-MBX is the device name listed in this FDA 510(k) record. The listed applicant is Triton Technology, Inc.. It received FDA 510(k) clearance on 1991-04-16 under 510(k) number K911448. The device is classified under product code FCK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPLE BIOPSY DEVICE-MBX?

MULTIPLE BIOPSY DEVICE-MBX is a medical device that received FDA 510(k) clearance on 1991-04-16. The listed applicant is Triton Technology, Inc.. The 510(k) number is K911448.

When did MULTIPLE BIOPSY DEVICE-MBX receive FDA 510(k) clearance?

MULTIPLE BIOPSY DEVICE-MBX received FDA 510(k) clearance on 1991-04-16, under 510(k) number K911448.

Who is the listed applicant for MULTIPLE BIOPSY DEVICE-MBX?

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

What is the FDA product code for MULTIPLE BIOPSY DEVICE-MBX?

The FDA product code for MULTIPLE BIOPSY DEVICE-MBX is FCK.

Related Clinical Trials

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Other records listing Triton Technology, 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.

K932142SUCTION GUILLOTINE DEVICEK902883TISSUE/POLYP TRAP SYSTEMK881303TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER

Related Devices (Code: FCK)

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.

K153763Howell Biliary Aspiration NeedleWilson-Cook Medical, Inc.K103326MULTIPLE BIOPSY SYSTEMUnited States Endoscopy Group, Inc.K062159RB12 SUCTION RECTAL BIOPSY SYSTEMAus Systems Pty , Ltd.K061201DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087United States Endoscopy Group, Inc.K051637DSNARE, MODEL 00711087United States Endoscopy Group, Inc.K954693MEHTA BRONCHIAL BIOSPY DRILLUnited States Endoscopy Group, 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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