Endosee System
FDA 510(k) K200038 · CooperSurgical, Inc.
510(k) numberK200038
Submission
- Device name
- Endosee System
- Applicant
- CooperSurgical, Inc.
Trumbull, CT, US - Received
- January 8, 2020
- Decision date
- February 5, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code HIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254294 | Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A…HIH · Traditional | Zhejiang Geyi Medical Instrument Co., Ltd. | 09/08/2026SE |
| K260984 | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)HIH · Traditional | Axora Medical, Inc. | 08/18/2026SE |
| K253020 | Strauss Surgical Resection InstrumentsHIH · Traditional | American Medical Endoscopy, Inc. | 06/04/2026SE |
| 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 |
|---|---|---|
| K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum…MQG · Traditional | 08/19/2026SE |
| K243799 | Fetal PillowPWB · Traditional | 08/29/2025SE |
| K250438 | CooperSurgical Milex® PessariesHHW · Traditional | 04/11/2025SE |
| K223064 | ALLY II Uterine Positioning System (UPS)LKF · Special | 10/28/2022SE |
| K201086 | Advincula Delineator Uterine ManipulatorHEW · Special | 05/21/2020SE |
| K191020 | G210 InviCell Plus with SignipHy pH monitoringPUB · Traditional | 01/14/2020SE |
| K191291 | Wallace Dual Lumen Oocyte Recovery SystemMQE · Special | 06/12/2019SE |
| K190639 | Endosee SystemHIH · Special | 05/15/2019SE |
| K182959 | Wallace Dual Lumen Oocyte Recovery SystemMQE · Traditional | 05/10/2019SE |
| K183020 | Endosee SystemHIH · Traditional | 01/31/2019SE |
Questions and answers
When was Endosee System cleared by the FDA?
Endosee System (K200038) received a 510(k) decision of Substantially Equivalent on February 5, 2020, 28 days after the submission was received.
What is the product code of K200038?
The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.