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510(k) K811548

CERVICAL SPATULA by Procedure Products, Inc. — Product Code HHT

K811548 is an FDA 510(k) premarket notification submitted by Procedure Products, Inc. for the device "CERVICAL SPATULA". The FDA issued a decision of Substantially Equivalent on June 23, 1981. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530. Procedure Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1981
Date Received
June 1, 1981
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 Procedure Products, Inc.

  • K161812 — Freedom Syringe (March 27, 2017)
  • K923194 — INSUFFLATOR CONNECTING FILTER (October 8, 1993)
  • K922536 — TORQUE DEVICE (December 10, 1992)
  • K914128 — CONNECTING SET (November 27, 1991)
  • K910673 — BAG SPIGOT (April 24, 1991)
  • K884985 — MODIFIED 10CC SYRINGE CONTROL RING SET (December 20, 1988)
  • K874747 — 10CC SYRINGE CONTROL RING SET (February 4, 1988)
  • K874037 — ANGIO WASTE FLUIDS DUMP BAG (January 29, 1988)
  • K853749 — CUSTOM CORONARY MANIFOLD KITS (January 13, 1986)
  • K842173 — DISPOSABLE STOPCOCKS (September 5, 1984)

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