BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO— 510(k) K926477

Name: FDA 510(k) clearance K926477
Creator: U.S. Food and Drug Administration
Published: 1993-11-12

Substantially Equivalent

Core Dynamics, Inc.

FDA 510(k) clearance K926477 for BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO, Substantially Equivalent on 1993-11-12. Applicant: Core Dynamics, Inc.. Device class: 1.

Clearance details

Applicant: Core Dynamics, Inc.
Product code: Code GBW
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1992-12-29
Decision date: 1993-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GBW

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K992904 — MINI-PORT1999-10-05
K992907 — INTRADUCER1999-10-05
K972112 — INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 314501997-12-01
K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN1996-08-08
K960426 — MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER1996-03-21

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

Adverse events under product code GBW

product code GBW

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K926477

K-number listed on FDA's recall record

Z-0129-2017 — CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.Class II·Terminated·ConMed Corporation·20160627
Z-0130-2017 — CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.Class II·Terminated·ConMed Corporation·20160627
Z-0132-2017 — CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.Class II·Terminated·ConMed Corporation·20160627
Z-0133-2017 — CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.Class II·Terminated·ConMed Corporation·20160627
Z-0134-2017 — CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic proceduresClass II·Terminated·ConMed Corporation·20160627
Z-0135-2017 — CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic proceduresClass II·Terminated·ConMed Corporation·20160627

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K926477.

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