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510(k) K081522

BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY by Bio Nuclear Diagnostics, Inc. — Product Code HHT

K081522 is an FDA 510(k) premarket notification submitted by Bio Nuclear Diagnostics, Inc. for the device "BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY". The FDA issued a decision of Substantially Equivalent on December 5, 2008. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2008
Date Received
May 30, 2008
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 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)
  • 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)
  • K041018 — DRG SOFTRELEASE (October 18, 2004)

FDA data resources