Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FBO · Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
127 daysmedian FDA review time
379 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K244001 | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ C | Karl Storz SE & CO. KG | 2025-05-02 | 127 | 0 |
| K243409 | KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) | Karl Storz SE & CO. KG | 2024-11-27 | 26 | 0 |
| K131364 | FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE | KARL STORZ Endoscopy-America, Inc. | 2014-01-02 | 234 | 0 |
| K082046 | KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODE | KARL STORZ Endoscopy-America, Inc. | 2008-10-10 | 84 | 0 |
| K080780 | ANCHORAGE SCOPE, MODEL 000003 | Epitek, Inc. | 2008-07-30 | 133 | 0 |
| K062918 | KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM | KARL STORZ Endoscopy-America, Inc. | 2007-01-17 | 111 | 0 |
| K061646 | LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & | Laserscope | 2006-06-27 | 15 | 0 |
| K011496 | CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, | Richard Wolf Medical Instruments Corp. | 2001-08-10 | 87 | 0 |
| K972979 | SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SM | Smith & Nephew, Inc. | 1997-12-11 | 122 | 0 |
| K962474 | OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) | Olympus America, Inc. | 1996-12-20 | 178 | 0 |
| K941992 | CYSTOSCOPE | Surgical Technologies, Inc. | 1995-11-30 | 584 | 0 |
| K951972 | CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERA | Cabot Medical Corp. | 1995-07-21 | 85 | 0 |
| K945185 | CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB) | KARL STORZ Endoscopy-America, Inc. | 1995-05-03 | 191 | 0 |
| K934649 | GALILEO ENDOSCOPES | Galileo Electro-Optics Corp. | 1994-10-13 | 379 | 0 |
| K943668 | KSEA CONTINOUS FLOW CYSTOSCOPE | KARL STORZ Endoscopy-America, Inc. | 1994-09-21 | 55 | 0 |
| K935163 | CONTINUOUS IRRIGATION CYSTOURETHROSCOPE | Richard Wolf Medical Instruments Corp. | 1994-09-07 | 313 | 0 |
| K904797 | SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) | Surgitek | 1991-03-05 | 133 | 0 |
| K870679 | VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE | Van-Tec, Inc. | 1987-03-30 | 39 | 0 |
| K843084 | OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE | Olympus Corp. | 1985-01-03 | 150 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda