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510(k) K983202

HARWILL MEDICAL CERVITULA CERVICAL SPATULA by Harwill Medical (Pty) , Ltd. — Product Code HHT

K983202 is an FDA 510(k) premarket notification submitted by Harwill Medical (Pty) , Ltd. for the device "HARWILL MEDICAL CERVITULA CERVICAL SPATULA". The FDA issued a decision of Substantially Equivalent on March 15, 1999. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530. Harwill Medical (Pty) , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1999
Date Received
September 14, 1998
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 Harwill Medical (Pty) , Ltd.

  • K992618 — RESPALERT (October 29, 1999)
  • K983204 — HARWILL MEDICAL U-KLIP UMBILICAL CLAMP (February 26, 1999)
  • K980550 — WHISTLE WATCH (August 27, 1998)

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