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510(k) K863145

CERVICAL SCRAPERS by Surgipath Medical Industries, Inc. — Product Code HHT

K863145 is an FDA 510(k) premarket notification submitted by Surgipath Medical Industries, Inc. for the device "CERVICAL SCRAPERS". The FDA issued a decision of Substantially Equivalent on August 19, 1986. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530. Surgipath Medical Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1986
Date Received
August 15, 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

Other clearances by Surgipath Medical Industries, Inc.

  • K883217 — SCHIFF REAGENT (August 5, 1988)
  • K881921 — C-E BRUSH (July 19, 1988)
  • K881922 — CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE (May 25, 1988)
  • K881659 — TISSUE SECTION ADHESIVE (April 21, 1988)
  • K863549 — REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (September 30, 1986)
  • K863616 — KNIFE MAKER (September 25, 1986)
  • K863548 — ROTARY MICROTOME (September 19, 1986)
  • K863483 — CASSETTE EMBOSSEER (September 16, 1986)
  • K861201 — FORMALDEHYDE SOLUTION, 37% (April 11, 1986)
  • K861270 — BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. (April 11, 1986)

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