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510(k) K963685

EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER by North Eos Industries, Inc. — Product Code HHT

K963685 is an FDA 510(k) premarket notification submitted by North Eos Industries, Inc. for the device "EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER". The FDA issued a decision of Substantially Equivalent on October 11, 1996. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530. North Eos Industries, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1996
Date Received
September 3, 1996
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 North Eos Industries, Inc.

  • K963377 — EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC (October 4, 1996)
  • K954614 — EOS BRAND DISPOSABLE PROCTOSCOPE (April 10, 1996)

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