Flexible Fiber Optic Gynecologic Endoscope
FDA 510(k) K922711 · Optimed Technologies, Inc.
510(k) numberK922711
Submission
- Device name
- Flexible Fiber Optic Gynecologic Endoscope
- Applicant
- Optimed Technologies, Inc.
Orange, CA, US - Received
- June 5, 1992
- Decision date
- May 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIH – Hysteroscope (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1690
- Specialty
- Obstetrics/Gynecology
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| K260984 | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)HIH · Traditional | Axora Medical, Inc. | 08/18/2026SE |
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| K254050 | Manual Tissue Removal DeviceHIH · Traditional | Suzhou AcuVu Medical Technology Co., Ltd. | 05/15/2026SE |
| K254251 | InnovexView (GC146-17, GC150-20, GC155-23)HIH · Traditional | Shanghai AnQing Medical Instrument Co., Ltd. | 02/26/2026SE |
| K252793 | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope…HIH · Traditional | Jiangsu Jiyuan Medical Technology Co., Ltd. | 12/18/2025SE |
| K252012 | SPY Cystoscope/HysteroscopeHIH · Special | Stryker Endoscopy | 07/18/2025SE |
| K243382 | RZ Resectoscope SystemHIH · Traditional | Rz Medizintechnik GmbH | 06/03/2025SE |
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G…HIH · Traditional | MacroLux Medical Technology Co., Ltd. | 08/16/2024SE |
| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)HIH · Special | Guangzhou Red Pine Medical Instrument Co., Ltd. | 08/02/2024SE |
More from Guangzhou Red Pine Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K972520 | OptiviewLLZ · Traditional | 09/29/1997SE |
| K955276 | Booster Lite 4 Motorized ScooterINI · Traditional | 11/04/1996SE |
| K955275 | Booster Trophy 5 Motorized ScooterINI · Traditional | 11/04/1996SE |
| K955274 | Booster Lite 3 Motorized ScooterINI · Traditional | 11/04/1996SE |
| K943598 | Flexible Fiber Optic LaparoscopesHET · Traditional | 10/18/1994SE |
| K926597 | Laparoscope, Gynecologic (and Accessories)HET · Traditional | 07/12/1994SE |
| K921942 | Hysteroscope (and Accessories)HIH · Traditional | 06/24/1994SE |
| K921985 | Arthroscope & AccessoriesHRX · Traditional | 06/29/1993SE |
| K922826 | Flexible Fiber Optic EndoscopeFGA · Traditional | 02/19/1993SE |
| K921883 | EndoscopeGCM · Traditional | 11/23/1992SE |
Questions and answers
When was Flexible Fiber Optic Gynecologic Endoscope cleared by the FDA?
Flexible Fiber Optic Gynecologic Endoscope (K922711) received a 510(k) decision of Substantially Equivalent on May 17, 1994, 711 days after the submission was received.
What is the product code of K922711?
The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.