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510(k) K862242

PAP SMEAR KIT by Quali-Med, Inc. — Product Code HHT

K862242 is an FDA 510(k) premarket notification submitted by Quali-Med, Inc. for the device "PAP SMEAR KIT". The FDA issued a decision of Substantially Equivalent on Jun 26, 1986. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530. Quali-Med, Inc. has 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 26, 1986
Date Received
Jun 12, 1986
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
510(k)

Other clearances by Quali-Med, Inc.

  • K871408 — BLOOD VESSEL CONNECTOR (Apr 27, 1987)
  • K862972 — DISPOSABLE MIRROR (Sep 23, 1986)
  • K862472 — QUARTZ RODS TITANIUM RODS (Sep 12, 1986)
  • K862241 — STANDARD BASIN KIT CUSTOM BASIN KIT (Aug 1, 1986)
  • K862172 — QUALI-MED'S OPERATING ROOM DRAPES (Jun 19, 1986)
  • K861198 — CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES) (May 16, 1986)

Other clearances for product code HHT

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

FDA data resources