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510(k) K930512

SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES by Core Dynamics, Inc. — Product Code GAZ

K930512 is an FDA 510(k) premarket notification submitted by Core Dynamics, Inc. for the device "SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES". The FDA issued a decision of Substantially Equivalent on July 23, 1993. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740. Core Dynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1993
Date Received
February 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Noninvasive
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
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)
  • K932021 — ENTREE CANNULA FASCIA ANCHORS (January 11, 1994)

Other clearances for product code GAZ

  • K952605 — SUCTION/IRRIGATOR TUBING KIT (September 15, 1995)
  • K945978 — TUBING, NONINVASIVE (January 11, 1995)
  • K911865 — NORTEC CONNECTING TUBE SET (November 1, 1991)
  • K910471 — MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE (March 8, 1991)
  • K910170 — MAXI-FLOW SUCTION SET 12 FT. (February 1, 1991)
  • K910171 — MAXI-FLOW SUCTION SET W/Y CONNECTOR (February 1, 1991)
  • K882315 — VIR-A-VAC EMPTY (September 26, 1988)
  • K883473 — SURGICAL CONNECTING TUBES (August 25, 1988)
  • K864964 — 5 - IN - 1 CONNECTOR (January 20, 1987)
  • K861757 — 5 IN 1 CONNECTOR (June 6, 1986)

FDA data resources