FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

K Number

K251469

Validate with FDA (Live)

Device Name

Endura Ureteral Stent and Stent Set

Manufacturer

Cathegenix (Xiamen) Co., Ltd.

Date Cleared

2025-12-19

(220 days)

Product Code

FAD

Regulation Number

876.4620

Type

Traditional

Panel

Gastroenterology/Urology

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K252480

Validate with FDA (Live)

Device Name

CE Deliver (DLV)

Manufacturer

Capsovision, Inc.

Date Cleared

2025-12-19

(134 days)

Product Code

NEZ

Regulation Number

876.1300

Type

Traditional

Panel

Gastroenterology/Urology

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K252284

Validate with FDA (Live)

Device Name

eMurmur Heart AI

Manufacturer

Csd Labs

Date Cleared

2025-12-19

(150 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K250914

Validate with FDA (Live)

Device Name

MediAI-BA

Manufacturer

Crescom Co., Ltd.

Date Cleared

2025-12-18

(266 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K252111

Validate with FDA (Live)

Device Name

Versius Surgical System (Versius Plus)

Manufacturer

Cmr Surgical Limited

Date Cleared

2025-12-16

(162 days)

Product Code

SCV

Regulation Number

878.4964

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K253118

Validate with FDA (Live)

Device Name

Companion Spine DIAM Instrumentation

Manufacturer

Companion Spine France

Date Cleared

2025-12-16

(83 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K250851

Validate with FDA (Live)

Device Name

Hypnos (369054-200)

Manufacturer

Cadwell Industries, Inc.

Date Cleared

2025-12-14

(268 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K253609

Validate with FDA (Live)

Device Name

TRAUMAGEL® 2.0 Hemostatic Gel

Manufacturer

Cresilon, Inc.

Date Cleared

2025-12-12

(24 days)

Product Code

QSY

Regulation Number

N/A

Type

Special

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K251936

Validate with FDA (Live)

Device Name

Ceribell Delirium Monitor System

Manufacturer

Ceribell, Inc.

Date Cleared

2025-12-08

(167 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K252126

Validate with FDA (Live)

Device Name

MitraPatch Mitral Valve Repair System

Manufacturer

Chawla Heart Technologies, LLC

Date Cleared

2025-12-04

(150 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

Search Results

510(k) Data Aggregation