# K971315: Auxiliary Instruments for Urs

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Sep 15, 1997 after 159 days
- Product code: FCL (Forceps, Biopsy, Non-Electric)
- Device class: 1
- Regulation: 21 CFR 876.1075
- Recalls of this device: 2 (0 Class I)
- 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) Various instruments for urological endoscopes (pre-enactment devices sold by Richard Wolf): named in the summary without a submission number
- (no number) Various instruments for urological endoscopes (Circon): named in the summary without a submission number
- (no number) Various instruments for urological endoscopes (Karl Storz): named in the summary without a submission number

## Recalls of this device
- Mar 24, 2023 · Class II · Z-1422-2023: Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions b
- Mar 24, 2023 · Class II · Z-1423-2023: Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions b

## Indications for use
General: The auxiliary instruments for ureteroscopes and uretero-renoscopes are used for preliminary procedures in the ureter and kidney, as well as for procedures in the urethra and bladder. Flexible and rigid auxiliary instruments can be used in connection with single or double instrument ports. Various diagnostic and therapeutic procedures can be performed, for example: « transurethral extraction of uretero calculi * biopsy for tumor diagnostics * removal of foreign bodies, e.g. ureteral stents The interventions are carried out by trained and experienced surgeons who consider the general condition and the anatomic specialties of the patient in their diagnosis. Forceps: The forceps are used for endoscopically controlled grasping and obtaining tissue specimens for diagnosis. Both flexible and rigid forceps are available. Stone Extractors: The stone extractors (graspers) are used to grasp stones or stone calculi and extract them out of urological tract. The stone extractor is also used to immobilize the calculus while disintegrating the stone. The stone extractors are intended for minimally invasive, diagnostic and therapeutic interventions. They are used e.g. in conjunction with ureteroscopes and uretero-renoscopes. Electrodes: Various electrodes are used for controlling bleeding and for removing or destruction of tissue by use of unipolar high-frequency current under endoscopic view. Bougies (Dilators): The bougies are used for the atraumatic distention of tubular organs. The flexible hollow dilators can be inserted over a guide wire, for example into the renal pelvis. The bougies are intended for minimally invasive, diagnostic and therapeutic interventions. Contraindications: Contraindications resulting from the general findings or described in the relevant literature must be observed.

Source page: https://510kreport.com/device/K971315
Methodology: https://510kreport.com/methodology