Atlas FDA

NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125

FDA 510(k) clearance K090202 · decided 2009-02-17

Clearance details

K-number
K090202
Device name
NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125
Applicant
Ncontact Surgical, Inc.
Decision
Substantially Equivalent
Date received
2009-01-27
Decision date
2009-02-17
Days to decision
21 days
Clearance type
Special
Product code
OCL
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Morrisville, NC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.