Device type
Hysteroscope (And Accessories)
Product code HIH · Class II · 21 CFR 884.1690 · Obstetrics/Gynecology
Recent 510(k)s
Sep 25, 2026
K254252
UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)
Karl Storz SE & CO. KG
- HIH
- Class II
Sep 18, 2026
K261102
UNIDRIVE Select System
Karl Storz SE & CO. KG
- HIH
- Class II
Sep 8, 2026
K254294
Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)
Zhejiang Geyi Medical Instrument Co., Ltd.
- HIH
- Class II
Aug 18, 2026
K260984
HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)
Axora Medical, Inc.
- HIH
- Class II
Recent recalls
Oct 7, 2026
Z-3299-2026
Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
Olympus Corporation of the Americas
- HIH
- Class II
- Ongoing
Oct 7, 2026
Z-3300-2026
Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
Olympus Corporation of the Americas
- HIH
- Class II
- Ongoing