Identity
- Trade Name
- Endosee Cystoscopy Kit FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Cystoscopy kit, flexible cystoscopy cannula and sterile drape, 10 of each FDA UDI
- Model / Reference
- OR-ESCX10KIT FDA UDI
- Description
- Cystoscopy kit, flexible cystoscopy cannula and sterile drape, 10 of each FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937022485 FDA UDI
- 510(k) Number
- K170660 FDA UDI
- FDA Product Code
- FAJ FDA UDIPUI FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical equipment/instrument drape, single-useFlexible video cystoscope, single-use
Endosee Cystoscopy Kit by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video cystoscope, single-use.
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- VersaVue Tablet - Global/CE Demo — MEDIMAGING INTEGRATED SOLUTION INC. · Class II
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Prosurg — Prosurg, Inc · Class II
- Aptra — OTU MEDICAL INC. · Class II
- Prosurg — Prosurg, Inc · Class II
Cleared under the same submission
K170660 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 4784c73e-8541-4ce4-b8ba-7b1e75fa1642 34 fields · synced Jun 9, 2026