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e-CFR data is current as of January 19, 2021

Title 21Chapter ISubchapter HPart 876Subpart F → §876.5090


Title 21: Food and Drugs
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
Subpart F—Therapeutic Devices


§876.5090   Suprapubic urological catheter and accessories.

(a) Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.

(b) Classification. (1) Class II (performance standards).

(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, 2001]

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