Last synced on 2 December 2022 at 11:04 pm

Urethrotome

Page Type
Product Code
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
876.4770
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.4770 Urethrotome

§ 876.4770 Urethrotome.

(a) Identification. A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It is a metal instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath. Some urethrotomes incorporate an optical channel for visual control.

(b) Classification. Class II (special 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.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019]

Urethrotome

Page Type
Product Code
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
876.4770
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.4770 Urethrotome

§ 876.4770 Urethrotome.

(a) Identification. A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It is a metal instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath. Some urethrotomes incorporate an optical channel for visual control.

(b) Classification. Class II (special 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.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019]