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Suprapubic Catheter Accessories

Page Type
Product Code
Definition
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.
Physical State
Introducer, access dilator, and peel-away sheath
Technical Method
The accessories are used to aid in placement of suprapubic catheters.
Target Area
Bladder, pubic tissue
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
876.5100
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5100 Suprapubic catheter accessories

§ 876.5100 Suprapubic catheter accessories.

(a) 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.

(b) Classification. 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.

[84 FR 14870, Apr. 12, 2019]

Suprapubic Catheter Accessories

Page Type
Product Code
Definition
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.
Physical State
Introducer, access dilator, and peel-away sheath
Technical Method
The accessories are used to aid in placement of suprapubic catheters.
Target Area
Bladder, pubic tissue
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
876.5100
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5100 Suprapubic catheter accessories

§ 876.5100 Suprapubic catheter accessories.

(a) 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.

(b) Classification. 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.

[84 FR 14870, Apr. 12, 2019]