21 CFR 888.5960 — Instrument, Cast Removal, Ac-Powered

Orthopedic (OR) · Part 888 Subpart E—Surgical Devices · § 888.5960

Identification

A cast removal instrument is an AC-powered, hand-held device intended to remove a cast from a patient. This generic type of device includes the electric cast cutter and cast vacuum.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
LGHInstrument, Cast Removal, Ac-Powered19
Innolitics

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