Desara TVez 3.0

FDA UDI

Class II (US FDA UDI)

by Caldera Medical, Inc.

Identity

Trade Name: Desara TVez 3.0 FDA UDI
Generic Name: Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
Device Name: Desara TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence FDA UDI
Model / Reference: CAL-DS01TV30 FDA UDI
Description: Desara TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence FDA UDI

Identifiers

Primary DI / UDI-DI: 00890594000155 FDA UDI
510(k) Number: K211975 FDA UDI
FDA Product Code: OTN FDA UDI
PWJ FDA UDI
GMDN Term: Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.3300 FDA UDI
884.4910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Female stress urinary incontinence surgical mesh-sling, synthetic polymer Transvaginal mesh-sling introduction needle

Desara TVez 3.0 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
Transvaginal 3.2 mm Introducer — CALDERA MEDICAL, INC. · Class II
Desara Blue TVez 2.7 — CALDERA MEDICAL, INC. · Class II

Cleared under the same submission

K211975 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: Caldera Medical, Inc.

Sources (1)

FDA UDI 5364be2c-f3ff-4089-8359-076eba177e46 36 fields · synced May 30, 2026