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510(k) K895659

HUI MINI-FLEX by Unimar, Inc. — Product Code HIG

K895659 is an FDA 510(k) premarket notification submitted by Unimar, Inc. for the device "HUI MINI-FLEX". The FDA issued a decision of Substantially Equivalent on December 19, 1989. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Unimar, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1989
Date Received
September 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Hysteroscopic
Device Class
Class II
Regulation Number
884.1700
Review Panel
OB
Submission Type

Other clearances by Unimar, Inc.

  • K932432 — KRONNER REINFORCING STYLETTE (April 12, 1994)
  • K920803 — HSG TRAY (October 19, 1992)
  • K910317 — UNI-SEM(TM) (May 1, 1991)
  • K904473 — KRONNER MANIPUJECTOR (December 14, 1990)
  • K895403 — ASPIRETTE ENDOCERVICAL ASPIRATOR (November 29, 1989)
  • K894264 — KDF-2.3 (August 15, 1989)
  • K890848 — CERVEX-BRUSH (May 11, 1989)
  • K854415 — ENDOMETRIAL PIPELLE (March 13, 1986)
  • K810291 — STERILE/DISPOSABLE HSG TRAY (March 18, 1981)

Other clearances for product code HIG

  • K261706 — Endomat Select (UP220) (July 16, 2026)
  • K251273 — Asurys Fluid Management System (March 27, 2026)
  • K240886 — Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System (July 25, 2024)
  • K210628 — X-FLO Fluid Management System (November 4, 2021)
  • K201355 — Endomat Select, IBS Shaver Software, License (July 22, 2020)
  • K180735 — Endomat Select (October 31, 2018)
  • K180825 — Fluent Fluid Management System (August 3, 2018)
  • K173489 — GYN-Pump PH304 (March 28, 2018)
  • K172040 — Aquilex Fluid Control System AQL-100S (February 5, 2018)
  • K172048 — FluidSmart (September 5, 2017)

FDA data resources