DeviceClearance

COSMAN COAGULATOR (CC-1) SYSTEM— 510(k) K973297

Substantially Equivalent

Radionics, Inc.

FDA 510(k) clearance K973297 for COSMAN COAGULATOR (CC-1) SYSTEM, Substantially Equivalent on 1997-10-29. Applicant: Radionics, Inc.. Device class: 2.

Clearance details

Applicant
Radionics, Inc.
Product code
Code GEI
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Burlington, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GEI

product code GEI
Death
133
Injury
7,585
Malfunction
35,808
Other
44
Total
43,570

Source: openFDA MAUDE database, through . 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 K973297

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K973297.

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