Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Olympus Winter & Ibe GmbH — Predicate Candidate Screening
43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
275 days90th percentile
43clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2 | Olympus Winter & Ibe GmbH | 2026-05-21 | 83 | 0 |
| K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applic | Olympus Winter & Ibe GmbH | 2025-09-23 | 85 | 0 |
| K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, | Olympus Winter & Ibe GmbH | 2023-08-18 | 63 | 2 |
| K221522 | HF-cables (resusable) | Olympus Winter & Ibe GmbH | 2023-01-19 | 238 | 0 |
| K223183 | Light-Guide Cables | Olympus Winter & Ibe GmbH | 2023-01-13 | 93 | 0 |
| K213207 | Sheath, Stopcock Accessory | Olympus Winter & Ibe GmbH | 2021-12-22 | 84 | 0 |
| K203492 | Instrument tray, for semi-rigid ureteroscope | Olympus Winter & Ibe GmbH | 2021-09-15 | 300 | 0 |
| K210651 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2021-08-03 | 152 | 1 |
| K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL | Olympus Winter & Ibe GmbH | 2021-05-17 | 151 | 0 |
| K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting | Olympus Winter & Ibe GmbH | 2021-04-28 | 173 | 4 |
| K200369 | OES Elite Ureteroscopes and Accessories | Olympus Winter & Ibe GmbH | 2020-08-28 | 196 | 0 |
| K190744 | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | Olympus Winter & Ibe GmbH | 2019-08-29 | 160 | 1 |
| K182587 | Device Electrosurgical Generator ESG-150 | Olympus Winter & Ibe GmbH | 2018-11-29 | 70 | 0 |
| K180200 | ESG-300, APU-300, Pressure Reducer, MAPC Probes | Olympus Winter & Ibe GmbH | 2018-04-26 | 92 | 0 |
| K171692 | Instrument basket, for EndoEYE | Olympus Winter & Ibe GmbH | 2018-04-02 | 299 | 0 |
| K172535 | Bipolar applicator CELON ProCurve V | Olympus Winter & Ibe GmbH | 2017-11-16 | 86 | 0 |
| K171965 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2017-09-28 | 90 | 1 |
| K161600 | Resection Electrodes | Olympus Winter & Ibe GmbH | 2016-09-06 | 89 | 0 |
| K160053 | Monopolar single-use HF cable | Olympus Winter & Ibe GmbH | 2016-05-06 | 116 | 0 |
| K160639 | Electrosurgical Generator ESG-200 | Olympus Winter & Ibe GmbH | 2016-05-04 | 58 | 0 |
| K160249 | ULTRA Telescopes | Olympus Winter & Ibe GmbH | 2016-04-21 | 80 | 0 |
| K153009 | ULTRA Telescopes | Olympus Winter & Ibe GmbH | 2016-04-05 | 174 | 0 |
| K151191 | OES ELITE Telescopes, Protective Tube | Olympus Winter & Ibe GmbH | 2015-11-24 | 204 | 0 |
| K152092 | Resection Electrodes | Olympus Winter & Ibe GmbH | 2015-10-26 | 90 | 1 |
| K150633 | ULTRA Telescopes | Olympus Winter & Ibe GmbH | 2015-04-29 | 49 | 0 |
| K140624 | HICURA HAND INSTRUMENTS | Olympus Winter & Ibe GmbH | 2014-12-10 | 274 | 0 |
| K142525 | PK Lap Loop | Olympus Winter & Ibe GmbH | 2014-11-21 | 74 | 0 |
| K141225 | ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P | Olympus Winter & Ibe GmbH | 2014-08-12 | 92 | 0 |
| K133311 | ENDOLED | Olympus Winter & Ibe GmbH | 2014-07-30 | 275 | 0 |
| K130819 | CLL- V1 LIGHT SOURCE | Olympus Winter & Ibe GmbH | 2013-06-19 | 86 | 0 |
| K120418 | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES | Olympus Winter & Ibe GmbH | 2012-06-20 | 131 | 1 |
| K110748 | OLYMPUS INSTRUMENT TRAY | Olympus Winter & Ibe GmbH | 2012-02-15 | 335 | 0 |
| K103032 | ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB5040 | Olympus Winter & Ibe GmbH | 2011-01-14 | 94 | 0 |
| K102781 | RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESEC | Olympus Winter & Ibe GmbH | 2011-01-11 | 106 | 1 |
| K100275 | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPOR | Olympus Winter & Ibe GmbH | 2010-07-01 | 150 | 1 |
| K090980 | HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, W | Olympus Winter & Ibe GmbH | 2009-06-29 | 83 | 0 |
| K050502 | SINGLE USE BALLOON DILATOR MAXPASSTM | Olympus Winter & Ibe GmbH | 2005-07-08 | 130 | 0 |
| K033222 | OLYMPUS STERILIZATION TRAYS | Olympus Winter & Ibe GmbH | 2004-08-02 | 304 | 0 |
| K033651 | OLYMPUS VIDEO URETEROSCOPE, NTSC | Olympus Winter & Ibe GmbH | 2004-01-30 | 71 | 0 |
| K020507 | OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND | Olympus Winter & Ibe GmbH | 2002-10-08 | 235 | 0 |
| K992141 | OLYMPUS WORKING ELEMENT FOR PROBES | Olympus Winter & Ibe GmbH | 1999-09-29 | 97 | 0 |
| K983811 | UNIPOLAR OPTICAL BIOPSY FORCEPS | Olympus Winter & Ibe GmbH | 1998-12-24 | 57 | 0 |
| K973232 | OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS | Olympus Winter & Ibe GmbH | 1997-11-21 | 85 | 0 |
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