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510(k) K800422

ADT MINI PERITONEAL LAVAGE KIT by A.D.T. Lab Industries — Product Code GBW

K800422 is an FDA 510(k) premarket notification submitted by A.D.T. Lab Industries for the device "ADT MINI PERITONEAL LAVAGE KIT". The FDA issued a decision of Substantially Equivalent on March 12, 1980. The device falls under product code GBW (Catheter, Peritoneal), a Class I device regulated under 21 CFR 878.4200. A.D.T. Lab Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1980
Date Received
February 26, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peritoneal
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by A.D.T. Lab Industries

  • K812297 — A.D.T. PROCEDURES TRAY (September 28, 1981)
  • K801753 — ADT BONE MARROW BIOPSY-ASPIR. NEELDE (August 20, 1980)
  • K801754 — ADT BONE MARROW ASPIRATION NEEDLE (August 20, 1980)
  • K800418 — ADT DISPOSABLE THIN NEEDLE ASPIRATION (April 28, 1980)
  • K800414 — ADT SOFT TISSUE BIOPSY TRAY (April 28, 1980)
  • K800410 — ADT BONE MARROW BIOPSY-ASPIRATION TRAY (April 28, 1980)
  • K800417 — ADT PTC PRO. TRAY W/(SKINNY CHIBA) NEEDL (April 28, 1980)
  • K800411 — ASPIRATION TRAY W/FERRIS DISP. ILLINOIS (April 28, 1980)
  • K800412 — ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW (April 28, 1980)
  • K800409 — ADT BONE MARROW BIOPSY ASPIRATION TRAY (April 28, 1980)

Other clearances for product code GBW

  • K992904 — MINI-PORT (October 5, 1999)
  • K992907 — INTRADUCER (October 5, 1999)
  • K972112 — INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 (December 1, 1997)
  • K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN (August 8, 1996)
  • K960426 — MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER (March 21, 1996)
  • K942709 — MEDIASTINAL SILICONE DRAINS (January 4, 1996)
  • K933510 — ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER (February 24, 1994)
  • K926477 — BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO (November 12, 1993)
  • K913733 — STERILE CHEST TUBE (October 8, 1991)
  • K894220 — HOUTS HYSTERECTOMY DRAIN (August 24, 1989)

FDA data resources