← Back to catalogue

Benesta Tissue Removal Device

FDA UDI

Class II (US FDA UDI)

by Caldera Medical, Inc.

Identity

Trade Name
Benesta Tissue Removal Device FDA UDI
Generic Name
Tissue morcellation system handpiece, battery-powered FDA UDI
Device Name
The Benesta Tissue Removal Device is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception. FDA UDI
Model / Reference
CAL-TR1511 FDA UDI
Description
The Benesta Tissue Removal Device is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception. FDA UDI

Identifiers

Primary DI / UDI-DI
00857492008096 FDA UDI
510(k) Number
K192811 FDA UDI
FDA Product Code
HIH FDA UDI
GMDN Term
Tissue morcellation system handpiece, battery-powered 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

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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tissue morcellation system handpiece, battery-powered

Benesta Tissue Removal Device by Caldera Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tissue morcellation system handpiece, battery-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Caldera Medical, Inc.

Sources (1)

  • FDA UDI 39430817-bc22-4cd5-9e24-3c1905ed4a21 36 fields · synced Jun 8, 2026