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Hysteroscope (And Accessories)
FDA product code HIH · Class 2 · Obstetrics/Gynecology
1,288
Registered devices
8,394
Adverse events
14
Recalls
171
510(k) clearances
Devices with this code
BETTOCCHI — Karl Storz GmbH & Co. KGUROLIFT ® — SCHÖLLY FIBEROPTIC GmbHUSA Series — Gyrus ACMI, LLCAED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NA — STRYKER CORPORATIONSHARK/S-LINE — Richard Wolf GmbHUROLIFT ® — SCHÖLLY FIBEROPTIC GmbHNA — STRYKER CORPORATIONUSA Elite — Gyrus ACMI, LLCAED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.SHARK/S-LINE — Richard Wolf GmbHOES HYSTEROFIBERSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.Olympus — OLYMPUS Winter & Ibe GmbHOlympus — OLYMPUS Winter & Ibe GmbHNA — STRYKER CORPORATIONUSA Elite — Gyrus ACMI, LLCNA — SCHÖLLY FIBEROPTIC GmbHTruClear — Covidien LPn.a. — Karl Storz GmbH & Co. KGGyrus ACMI — Gyrus ACMI, LLCAveta Coral Disposable Hysteroscope — MEDITRINA, INC.TruClear — Covidien LPn.a. — Karl Storz GmbH & Co. KGNA — STRYKER CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-21 | Karl Storz Endoscopy | Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecolo |
| 2025-11-11 | Olympus Corporation of the Americas | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| 2025-06-18 | Olympus Corporation of the Americas | Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F |
| 2025-06-18 | Olympus Corporation of the Americas | Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F |
| 2024-04-18 | Olympus Corporation of the Americas | The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and c |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the |
| 2023-07-20 | Olympus Corporation of the Americas | IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes. |
| 2023-06-23 | Scholly Fiberoptic Gmbh | There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the w |
| 2022-06-07 | Covidien Llc | Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch. |
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