Identity
- Trade Name
- Winged Guide Accessory FDA UDI
- Generic Name
- Transobturator needle, reusable FDA UDI
- Device Name
- The Winged Guide Accessory may be referred to as the winged guide or guide and is for use with the Caldera Medical Inside-Out introducers only. FDA UDI
- Model / Reference
- CAL-WI FDA UDI
- Description
- The Winged Guide Accessory may be referred to as the winged guide or guide and is for use with the Caldera Medical Inside-Out introducers only. FDA UDI
Identifiers
- Catalog Number
- CAL-WI FDA UDI
- Primary DI / UDI-DI
- 00890594000278 FDA UDI
- 510(k) Number
- K172614 FDA UDI
- FDA Product Code
- PWJ FDA UDI
- GMDN Term
- Transobturator needle, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
No
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Transobturator needle, reusable
Winged Guide Accessory by Caldera Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transobturator needle, reusable.
- Transobturator Helical, Right Introducer — CALDERA MEDICAL, INC. · Class II
- Transobturator Helical, Left Introducer — CALDERA MEDICAL, INC. · Class II
- Transobturator Inside-Out, Right Introducer — CALDERA MEDICAL, INC. · Class II
- Transobturator Inside-Out, Left 3.2 mm Introducer — CALDERA MEDICAL, INC. · Class II
- Transobturator Large Helical, Right Introducer — CALDERA MEDICAL, INC. · Class II
- Transobturator Inside-Out, Right 3.2 mm Introducer — CALDERA MEDICAL, INC. · Class II
- Transobturator Inside-Out, Left Introducer — CALDERA MEDICAL, INC. · Class II
- Transobturator Hook Introducer — CALDERA MEDICAL, INC. · Class II
Cleared under the same submission
K172614 also covers:
- Suprapubic Introducer — CALDERA MEDICAL, INC.
- Transobturator Helical, Left Introducer — CALDERA MEDICAL, INC.
- Transobturator Helical, Left Introducer — CALDERA MEDICAL, INC.
- Transobturator Helical, Right Introducer — CALDERA MEDICAL, INC.
- Transobturator Helical, Right Introducer — CALDERA MEDICAL, INC.
- Transobturator Hook Introducer — CALDERA MEDICAL, INC.
- Transobturator Inside-Out, Left 3.2 mm Introducer — CALDERA MEDICAL, INC.
- Transobturator Inside-Out, Left Introducer — CALDERA MEDICAL, INC.
- Transobturator Inside-Out, Right 3.2 mm Introducer — CALDERA MEDICAL, INC.
- Transobturator Inside-Out, Right Introducer — CALDERA MEDICAL, INC.
- Transobturator Large Helical, Left Introducer — CALDERA MEDICAL, INC.
- Transobturator Large Helical, Right Introducer — CALDERA MEDICAL, INC.
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 9d302e58-cfe6-4421-84f0-2e95051629f4 37 fields · synced May 30, 2026