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FDA 510(k)

HUI MINI-FLEX

K-Number: K895659 · 1989-12-19

ApplicantUnimar, Inc.
Decision Date1989-12-19
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HUI MINI-FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Unimar, Inc.. It received FDA 510(k) clearance on 1989-12-19 under 510(k) number K895659. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUI MINI-FLEX?

HUI MINI-FLEX is a medical device that received FDA 510(k) clearance on 1989-12-19. The listed applicant is Unimar, Inc.. The 510(k) number is K895659.

When did HUI MINI-FLEX receive FDA 510(k) clearance?

HUI MINI-FLEX received FDA 510(k) clearance on 1989-12-19, under 510(k) number K895659.

Who is the listed applicant for HUI MINI-FLEX?

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

What is the FDA product code for HUI MINI-FLEX?

The FDA product code for HUI MINI-FLEX is HIG.

Other records listing Unimar, 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.

K932432KRONNER REINFORCING STYLETTEK920803HSG TRAYK910317UNI-SEM(TM)K904473KRONNER MANIPUJECTORK895403ASPIRETTE ENDOCERVICAL ASPIRATORK894264KDF-2.3

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Related Devices (Code: HIG)

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.

K261706Endomat Select (UP220)KARL STORZ SE & CO. KGK251273Asurys Fluid Management SystemBoston Scientific CorporationK240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)Hologic, Inc.K210628X-FLO Fluid Management SystemThermedx, LLCK201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KGK180735Endomat SelectKarl Storz SE & CO. KG

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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