21 CFR 876.5100 — Suprapubic Catheter Accessories

Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5100

Identification

Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath.

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
QGCSuprapubic Catheter Accessories10
Innolitics

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