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510(k) K926477

BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO by Core Dynamics, Inc. — Product Code GBW

K926477 is an FDA 510(k) premarket notification submitted by Core Dynamics, Inc. for the device "BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO". The FDA issued a decision of Substantially Equivalent on November 12, 1993. The device falls under product code GBW (Catheter, Peritoneal), a Class I device regulated under 21 CFR 878.4200. Core Dynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1993
Date Received
December 29, 1992
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 Core Dynamics, Inc.

  • K992250 — CORE AUDIBLE TROCAR II (September 24, 1999)
  • K992190 — CORE POUCH (September 1, 1999)
  • K955490 — LAPAROSCOPIC KNITTER (January 22, 1996)
  • K953903 — LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM (October 20, 1995)
  • K953409 — LAPAROSCOPIC TROCAR (October 16, 1995)
  • K950457 — CANNUAL AND TROCAR, SUPERPUBIC (May 5, 1995)
  • K943172 — CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR (July 28, 1994)
  • K935826 — LAPAROSCOPIC/SUCTION/IRRIGATION PROBE (May 18, 1994)
  • K932118 — ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET (March 17, 1994)
  • K932020 — ENTREE BLUNT TIP TROCAR AND ADAPTER (January 11, 1994)

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)
  • K913733 — STERILE CHEST TUBE (October 8, 1991)
  • K894220 — HOUTS HYSTERECTOMY DRAIN (August 24, 1989)
  • K894119 — MADEGOM LTDA. PENROSE DRAIN TUBING (August 18, 1989)

FDA data resources