Home › Device types › HIH
Hysteroscope (And Accessories)
FDA product code HIH · Class 2 · Obstetrics/Gynecology
1,289
Registered devices
8,734
Adverse events
16
Recalls
175
510(k) clearances
Devices with this code
NA — STRYKER CORPORATIONOlympus — OLYMPUS Winter & Ibe GmbHn.a. — Karl Storz GmbH & Co. KGHysteroscopy sheath — SOPRO-COMEG GmbHB.I.O.H. — Karl Storz GmbH & Co. KGStandard Hystero Grasper, D/A, 3mm x 37cm — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NA — Richard Wolf GmbHn.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGNA — STRYKER CORPORATIONNA — STRYKER CORPORATIONLarge Biopsy Cup Forcep, D/A, 3mm x 37cm — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.PrimeSight — SCHÖLLY FIBEROPTIC GmbHGYNECARE VERSAPOINT — Ethicon Inc.AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.SlimLine — Gyrus ACMI, LLCUSA Elite — Gyrus ACMI, LLCNA — STRYKER CORPORATIONOlympus — OLYMPUS Winter & Ibe GmbHNA — STRYKER CORPORATIONOlympus — OLYMPUS Winter & Ibe GmbHEndosee — Coopersurgical, Inc.AED HS74216 Hystero-Pro Rotatable Hook Scissors, 5FR x 40cm, S/A — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.USA Elite System — Gyrus ACMI, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-24 | Olympus Corporation of the Americas | There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japane |
| 2026-08-24 | Olympus Corporation of the Americas | There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japane |
| 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.