DeviceClearance

PRELOADED TISSUE MARKER DEVICE— 510(k) K100994

Substantially Equivalent

Carbon Medical Technologies, Inc.

FDA 510(k) clearance K100994 for PRELOADED TISSUE MARKER DEVICE, Substantially Equivalent on 2010-04-30. Applicant: Carbon Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant
Carbon Medical Technologies, Inc.
Product code
Code NEU
Device class
Class 2
Regulation
21 CFR 878.4300
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
St. Paul, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NEU

product code NEU
Injury
824
Total
824

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 K100994

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 K100994.

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