# K972979: Smith & Nephew Images Cystourethroscopes and Accessories, Smith & Nephew SEMI0RIGID and Flexible Manual Surgical Instrum

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 11, 1997 after 122 days
- Product code: FBO (Cystourethroscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Karl Storz Endoscopy Cystourethroscopes and accessories: named in the summary without a submission number

## Indications for use
Smith & Nephew Images Cystourethroscopes are indicated for use in the examination of the bladder, urethra and distal ureter, and, using additional accessories, to perform various diagnostic and therapeutic procedures. Smith & Nephew Semi-rigid and Flexible Manual Instruments are indicated for use in the endoscopic examination of the bladder, urethra and distal ureters and to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K972979
Methodology: https://510kreport.com/methodology