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FDA PRODUCT CODE · CLASS II

OTK — Wound Drain Catheter System

For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4780
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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