Identity
- Trade Name
- Benesta Hysteroscope Set FDA UDI
- Generic Name
- Rigid optical hysteroscope FDA UDI
- Device Name
- Benesta Rod Lens Hysteroscope for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative/surgical procedures. The Set contains: CAL-TR113 Benesta Hysteroscope CAL-TR112 Benesta Outflow Channel CAL-TR121 Benesta Hysteroscope Light Source Adapter (Storz/Olympus) CAL-TR122 Benesta Hysteroscope Light Source Adapter (Dyonics/Wolf) CAL-TR123 Benesta Stopcock Lever and Cap (2 each) CAL-TR124 Benesta Hysteroscope/Outflow Channel End Cap (2 each) CAL-TR125 Benesta Working Channel Brush, 3mm CAL-TR126 Benesta Inflow Channel Brush, 2mm FDA UDI
- Model / Reference
- CAL-TR111 FDA UDI
- Description
- Benesta Rod Lens Hysteroscope for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative/surgical procedures. The Set contains: CAL-TR113 Benesta Hysteroscope CAL-TR112 Benesta Outflow Channel CAL-TR121 Benesta Hysteroscope Light Source Adapter (Storz/Olympus) CAL-TR122 Benesta Hysteroscope Light Source Adapter (Dyonics/Wolf) CAL-TR123 Benesta Stopcock Lever and Cap (2 each) CAL-TR124 Benesta Hysteroscope/Outflow Channel End Cap (2 each) CAL-TR125 Benesta Working Channel Brush, 3mm CAL-TR126 Benesta Inflow Channel Brush, 2mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857492008041 FDA UDI
- 510(k) Number
- K192822 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Rigid optical hysteroscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5.8 Millimeter FDA UDI
Category: Rigid optical hysteroscope
Benesta Hysteroscope Set by Caldera Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical hysteroscope.
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- TRUCLEAR — Smith & Nephew, Inc. · Class II
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- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- Gimmi — Gimmi GmbH · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
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 |
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Manufacturer
- Manufacturer
- Caldera Medical, Inc.
Sources (1)
- FDA UDI 6cf0cdbe-317a-44f7-9183-87c4489e40cb 37 fields · synced May 30, 2026