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FDA 510(k)

LAPAROSCOPIC CLEANING BRUSH INSTRUMENT

K-Number: K911481 · 1991-04-22

ApplicantUnited States Endoscopy Group, Inc.
Decision Date1991-04-22
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC CLEANING BRUSH INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 1991-04-22 under 510(k) number K911481. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROSCOPIC CLEANING BRUSH INSTRUMENT?

LAPAROSCOPIC CLEANING BRUSH INSTRUMENT is a medical device that received FDA 510(k) clearance on 1991-04-22. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K911481.

When did LAPAROSCOPIC CLEANING BRUSH INSTRUMENT receive FDA 510(k) clearance?

LAPAROSCOPIC CLEANING BRUSH INSTRUMENT received FDA 510(k) clearance on 1991-04-22, under 510(k) number K911481.

Who is the listed applicant for LAPAROSCOPIC CLEANING BRUSH INSTRUMENT?

The FDA 510(k) record lists United States Endoscopy Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAPAROSCOPIC CLEANING BRUSH INSTRUMENT?

The FDA product code for LAPAROSCOPIC CLEANING BRUSH INSTRUMENT is FDX.

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Related Devices (Code: FDX)

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.

K250993Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems CorporationK220063Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., Ltd.K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc.K191485Deflectable Brush Biopsy SetCook IncorporatedK182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook IncorporatedK181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, 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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