21 CFR 876.4530 — Retractor, Fiberoptic

Gastroenterology, Urology (GU) · Subpart E—Surgical Devices · § 876.4530

Identification

A gastroenterology-urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system that is used to illuminate deep surgical sites.

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 § 876.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
FDGRetractor, Fiberoptic12
Innolitics

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