Identity
- Trade Name
- Transvaginal 3.2 mm Introducer FDA UDI
- Generic Name
- Transvaginal mesh-sling introduction needle FDA UDI
- Device Name
- Transvaginal 3.2 mm Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion and placement of Desara surgical mesh. FDA UDI
- Model / Reference
- CAL-TV32 FDA UDI
- Description
- Transvaginal 3.2 mm Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion and placement of Desara surgical mesh. FDA UDI
Identifiers
- Catalog Number
- CAL-TV32 FDA UDI
- Primary DI / UDI-DI
- 00890594000865 FDA UDI
- 510(k) Number
- K172614 FDA UDI
- FDA Product Code
- PWJ FDA UDI
- GMDN Term
- Transvaginal mesh-sling introduction needle 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Transvaginal mesh-sling introduction needle
Transvaginal 3.2 mm Introducer by Caldera Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transvaginal mesh-sling introduction needle.
- Greenwald Surgical Company, Inc. — GRACE MANUFACTURING INC · Class I
- Greenwald Surgical Company, Inc. — GRACE MANUFACTURING INC · Class I
- Male Remeex System - Thread Passer — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL · Class II
- Remeex System - Thread Passer — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL · Class II
- Greenwald Surgical Company, Inc. — GRACE MANUFACTURING INC · Class I
- Desara Blue TVez 3.0 — CALDERA MEDICAL, INC. · Class II
- Desara Blue TVez 2.7 — CALDERA MEDICAL, INC. · Class II
- Desara TVez 3.0 — 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 4d3fec2a-5701-42f9-98c4-f54f1f3f5f86 37 fields · synced Jun 8, 2026