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Panels › Obstetrics/Gynecology › Product code HIH · Class 2

Hysteroscope (And Accessories)

Regulation 884.1690

8510(k)s in 12 months (175 all time)
4recalls in 12 months (16 all time)
16recalls that name a 510(k)
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Top companies in HIH

Company510(k)sRecalls
Hologic, Inc.130
KARL STORZ Endoscopy-America, Inc.110
Smith & Nephew, Inc.100
CooperSurgical, Inc.52
Olympus Corporation of the Americas07
Richard Wolf Medical Instruments Corp.61
Interlace Medical, Inc.60
Imagyn Medical, Inc.50
Meditrina, Inc.50
Karl Storz Endoscopy31
DateFirm and productCodeLinked 510(k)
Sep 25, 2026Olympus Corporation of the Americas
Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
Open, Classified		 HIHK890328
Sep 25, 2026Olympus Corporation of the Americas
Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
Open, Classified		 HIHK890328
Jul 23, 2026Karl Storz Endoscopy
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
Open, Classified		 HIHK961605
Feb 20, 2026Olympus Corporation of the Americas
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
Open, Classified		 HIHK210651
Jul 21, 2025Olympus Corporation of the Americas
Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some co
Open, Classified		 HIHK890328
Jul 21, 2025Olympus Corporation of the Americas
Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen whi
Open, Classified		 HIHK890328
Jun 6, 2024Olympus Corporation of the Americas
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Open, Classified		 HIHK897003
Nov 17, 2023Aizu Olympus Co., Ltd.
Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
Open, Classified		 HIHK221557
Nov 17, 2023Aizu Olympus Co., Ltd.
Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
Open, Classified		 HIHK891451
Aug 29, 2023Olympus Corporation of the Americas
Visera Hysterovideoscope Olympus HYF Type V
Open, Classified		 HIHK022445
K221557
Aug 9, 2023Scholly Fiberoptic Gmbh
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO
Open, Classified		 HIHK150158
Jun 7, 2022Covidien Llc
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
Open, Classified		 HIHK031787
K132015
Apr 9, 2020CooperSurgical, Inc.
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Terminated		 HIHK183020
Dec 13, 2019CooperSurgical, Inc.
ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of th
Terminated		 HIHK190639
Jun 13, 2019Richard Wolf Medical Instruments Corp.
E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product U
Terminated		 HIHK980302
Feb 2, 2005Ethicon, Inc
VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville
Terminated		 HIHK962482

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