SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES— 510(k) K930512

Name: FDA 510(k) clearance K930512
Creator: U.S. Food and Drug Administration
Published: 1993-07-23

Substantially Equivalent

Core Dynamics, Inc.

FDA 510(k) clearance K930512 for SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES, Substantially Equivalent on 1993-07-23. Applicant: Core Dynamics, Inc.. Device class: 2.

Clearance details

Applicant: Core Dynamics, Inc.
Product code: Code GAZ
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1993-02-01
Decision date: 1993-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAZ

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K952605 — SUCTION/IRRIGATOR TUBING KIT1995-09-15
K945978 — TUBING, NONINVASIVE1995-01-11
K911865 — NORTEC CONNECTING TUBE SET1991-11-01
K910471 — MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE1991-03-08
K910170 — MAXI-FLOW SUCTION SET 12 FT.1991-02-01

More clearances from Core Dynamics, Inc.

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K992250 — CORE AUDIBLE TROCAR II1999-09-24
K992190 — CORE POUCH1999-09-01
K955490 — LAPAROSCOPIC KNITTER1996-01-22
K953903 — LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM1995-10-20
K953409 — LAPAROSCOPIC TROCAR1995-10-16

Recalls naming K930512

K-number listed on FDA's recall record

Z-0131-2017 — CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD8200) is indicated for use in gynecological and abdominal surgery forClass II·Terminated·ConMed Corporation·20160627

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K930512.

Data sourced from openFDA. This site is unofficial and independent of the FDA.