510(k) · Cleared
Recalled · Class II · 2023Auxiliary Instruments for Urs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · FCL Forceps, Biopsy, Non-Electric
Cleared on Sep 15, 1997 after a 159-day review. The FDA summary names its predicate without a number. It has been recalled 2 times.
- Decided
- Sep 15, 1997
- Review
- 159 days
- Class
- Class I
- Product code
- FCL
- Recalls
- 2
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FCL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Various instruments for urological endoscopes (pre-enactment devices sold by Richard Wolf) Named without a submission number | |
| * | — | Various instruments for urological endoscopes (Circon) Named without a submission number | |
| * | — | Various instruments for urological endoscopes (Karl Storz) Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2023 | Class II | Z-1422-2023 | Under Investigation by firm | 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 begin even with a slight bending of the… |
| Mar 24, 2023 | Class II | Z-1423-2023 | Under Investigation by firm | 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 begin even with a slight bending of the… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All FCL devicesFCL Forceps, Biopsy, Non-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCL
FDA has decided no FCL device since 2007.
Median 510(k) review, days · FCL
Too few FCL 510(k)s in any year since 2007 to give a median.
Recalls per year · FCL
3in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCL
55in 2025
MAUDE reports naming product code FCL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 58 |
| 2008 | 0 | — | 0 | 153 |
| 2009 | 0 | — | 0 | 410 |
| 2010 | 0 | — | 3 | 495 |
| 2011 | 0 | — | 0 | 377 |
| 2012 | 0 | — | 0 | 97 |
| 2013 | 0 | — | 0 | 58 |
| 2014 | 0 | — | 0 | 86 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 64 |
| 2017 | 0 | — | 0 | 275 |
| 2018 | 0 | — | 0 | 69 |
| 2019 | 0 | — | 0 | 69 |
| 2020 | 0 | — | 0 | 53 |
| 2021 | 0 | — | 0 | 30 |
| 2022 | 0 | — | 0 | 70 |
| 2023 | 0 | — | 0 | 68 |
| 2024 | 0 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 55 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
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 *…
Read the full statement (258 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971315 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971315: Auxiliary Instruments for Urs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971315
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026