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510(k) K041018

DRG SOFTRELEASE by Doctor'S Research Group, Inc. — Product Code HHT

K041018 is an FDA 510(k) premarket notification submitted by Doctor'S Research Group, Inc. for the device "DRG SOFTRELEASE". The FDA issued a decision of Substantially Equivalent on October 18, 2004. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530. Doctor'S Research Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2004
Date Received
April 20, 2004
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 Doctor'S Research Group, Inc.

  • K051487 — DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE (December 22, 2005)
  • K012535 — DRG DISPOSABLE VAGINAL SPECULUM (March 1, 2002)
  • K012003 — DRG REACTION CHAMBER/SAFETY TIP (February 12, 2002)
  • K011736 — DRG QUICKMIX (January 30, 2002)
  • K013786 — DRG ORTHOHEX SS BONE SCREW (December 17, 2001)
  • K002047 — DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT (November 22, 2000)
  • K991714 — DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00 (December 10, 1999)
  • K990212 — LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 (September 14, 1999)
  • K990920 — DRG TITANIUM BONE PLATE (June 10, 1999)
  • K981881 — DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRIL (December 2, 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