Reserved Medical Devices
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The following devices are devices that FDA believes meet the reserved
criteria in section 206 of the Modernization Act and, therefore, would remain
subject to premarket notification under new section 510(l) added to the act:
Footnotes:
2 |
Exemption is limited to manual devices. |
8 |
Exemption is limited to uses as a skin protectant. |
15 |
Exemption does not apply if used as folders and injectors for soft or foldable IOL's. |
16 |
Exemption does not apply when indicated for infants. |
18 |
Only chairs without operative unit device are 510(k) exempt.
Dental chair with operative unit, product code KLC, requires 510(k) clearance.
Dental chair without operative unit, product code NRU, is exempt from 510(k). |
21 |
Only the accessories tray to the unit is 510(k) exempt.
Dental operative unit, product code EIA, requires 510(k) clearance.
Oral cavity evacuator, product code EHZ , is exempt from 510(k).
Saliva ejector mouthpiece, product code DYN , is exempt from 510(k).
Suction operatory unit, product code EBR, is exempt from 510(k).
Operative dental unit accessories, product code NRD, is exempt from 510(k). |
80 |
510(k) exempt only when the device is made of common celluosic and synthetic material with an established safety profile. |
96 |
Exemption is limited to ataxiagraphs that do not provide an interpretation or a clinical implication of the measurement |
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