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510(k) K890848

CERVEX-BRUSH by Unimar, Inc. — Product Code HHT

K890848 is an FDA 510(k) premarket notification submitted by Unimar, Inc. for the device "CERVEX-BRUSH". The FDA issued a decision of Substantially Equivalent on May 11, 1989. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530. Unimar, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1989
Date Received
February 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spatula, Cervical, Cytological
Device Class
Class II
Regulation Number
884.4530
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)
  • K895659 — HUI MINI-FLEX (December 19, 1989)
  • K895403 — ASPIRETTE ENDOCERVICAL ASPIRATOR (November 29, 1989)
  • K894264 — KDF-2.3 (August 15, 1989)
  • K854415 — ENDOMETRIAL PIPELLE (March 13, 1986)
  • K810291 — STERILE/DISPOSABLE HSG TRAY (March 18, 1981)

Other clearances for product code HHT

  • K182049 — exCellerator Cervical Collection Device (April 25, 2019)
  • K153128 — Kolplast Cervical Sample Collection Kit (January 13, 2017)
  • K141057 — DISPOSABLE CERVICAL BRUSH (May 14, 2015)
  • K111681 — HISTOBRUSH (January 19, 2012)
  • K083012 — PAPCONE (April 9, 2009)
  • K081522 — BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY (December 5, 2008)
  • K072381 — SOFTPAP CERVICAL CELL COLLECTOR (January 30, 2008)
  • K062433 — DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM (March 16, 2007)
  • K043369 — CERVEX-BRUSH COMBI (February 2, 2005)
  • K042527 — SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 (November 8, 2004)

FDA data resources