LAPAROMED CHOLANGIOGRAM VACUUM DEVICE— 510(k) K910218

Name: FDA 510(k) clearance K910218
Creator: U.S. Food and Drug Administration
Published: 1991-04-08

Substantially Equivalent

Laparomed Corp.

FDA 510(k) clearance K910218 for LAPAROMED CHOLANGIOGRAM VACUUM DEVICE, Substantially Equivalent on 1991-04-08. Applicant: Laparomed Corp.. Device class: 2.

Clearance details

Applicant: Laparomed Corp.
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1991-01-17
Decision date: 1991-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K934527 — FASCIA STITCHER1994-02-25
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K921921 — CATHETER CHOLANGIOGRAPHY1992-08-17
K921053 — LAPAROMED LIGATING LOOP1992-08-06
K921006 — LAPAROSCOPIC RETRACTOR SYSTEM1992-07-28

Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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 →

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