Product Code: KGD FDA class 2 21 CFR 876.1500

Scissors For Cystoscope

Gastroenterology, Urology

Scissors for Cystoscope are endoscopic surgical instruments designed for use through a cystoscope, enabling the cutting or excision of tissue within the urinary bladder or urethra under endoscopic visualization without the need for open surgery. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KGD, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology medical specialty.

510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
6

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Basic Information

Product Code
KGD
Device Class
FDA class 2
Regulation Number
876.1500
Medical Specialty
Gastroenterology, Urology
Review Panel
GU
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K944054 POWDER FREE SURGEON'S GLOVE
K891902 CHISELS- FREER, LUCAS, ALEXANDER, BISHOP