Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt
Medical specialty
General, Plastic Surgery
Device class
2
Regulation number
878.4495
Review panel
SU
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
This product code is the class II exempt counterpart of GAQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.