Home / 510(k) Clearances / K823331

510(k) K823331

PC-204 TUNNELOR by Medigroup — Product Code FKX

K823331 is an FDA 510(k) premarket notification submitted by Medigroup for the device "PC-204 TUNNELOR". The FDA issued a decision of Substantially Equivalent on January 26, 1983. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Medigroup has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1983
Date Received
November 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Medigroup

  • K120130 — FALLER TROCAR (May 21, 2012)
  • K071167 — FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 (August 31, 2007)
  • K070730 — FLEX-NECK ARC CATHETER (July 3, 2007)
  • K060897 — EMBEDDING TOOL, MODEL TE-1000 (July 18, 2006)
  • K031351 — FLEX-NECK PD CATHETER, INFANT (September 17, 2003)
  • K974570 — PERITONEAL DIALYSIS CATHETER CONNECTOR (February 27, 1998)
  • K823294 — MEDIGROUP LS-110 LIGHT SOURCE (May 9, 1983)
  • K823295 — MEDIGROUP 2.2MM NEEDLESCOPE CANNULA& (May 6, 1983)
  • K823297 — ST-610 NEEDLESCOPE STERILIZATION TRAY (May 6, 1983)
  • K823293 — MEDIGROUP LG-102 LIGHT GUIDE (May 5, 1983)

Other clearances for product code FKX

  • K250523 — Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes S (October 2, 2025)
  • K243371 — Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 (May 16, 2025)
  • K220935 — Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supe (December 29, 2022)
  • K222318 — Fresenius Liberty Select Cycler (October 31, 2022)
  • K212522 — Lilliput APD System (April 15, 2022)
  • K212658 — CloudCath Peritoneal Dialysis Drain Set Monitoring System (February 9, 2022)
  • K201867 — Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the (November 19, 2020)
  • K181108 — Fresenius Liberty Select Cycler (May 24, 2018)
  • K173718 — Liberty Cycler Set (May 1, 2018)
  • K171652 — Fresenius Liberty Select Cycler (September 15, 2017)

FDA data resources