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

K Number

Validate with FDA (Live)

Device Name

Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)

Manufacturer

Technomed Europe

Date Cleared

2026-03-15

(118 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253391

Validate with FDA (Live)

Device Name

Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)

Manufacturer

Medtronic Navigation, Inc.

Date Cleared

2026-03-13

(164 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253205

Validate with FDA (Live)

Device Name

OptiMap Catheter - 50mm (OPTI-CATH2-50)

Manufacturer

Cortex, Inc.

Date Cleared

2026-03-13

(168 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253987

Validate with FDA (Live)

Device Name

BARE Wireguided Balloon Dilation Catheter (1235)

Manufacturer

GIE Medical

Date Cleared

2026-03-13

(91 days)

Product Code

FGE

Regulation Number

876.5010

Type

Traditional

Panel

Gastroenterology/Urology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253799

Validate with FDA (Live)

Device Name

SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)

Manufacturer

Pressure Products Medical Device Manufacturing, LLC

Date Cleared

2026-03-13

(105 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K251999

Validate with FDA (Live)

Device Name

Promogran Prisma Collagen Matrix with ORC and Silver

Manufacturer

Solventum Germany GmbH

Date Cleared

2026-03-13

(259 days)

Product Code

FRO

Regulation Number

N/A

Type

Traditional

Panel

General & Plastic Surgery

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K252648

Validate with FDA (Live)

Device Name

Niti-S SPAXUS Stent

Manufacturer

Taewoong Medical Co., Ltd.

Date Cleared

2026-03-13

(204 days)

Product Code

PCU

Regulation Number

876.5015

Type

Traditional

Panel

Gastroenterology/Urology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K252249

Validate with FDA (Live)

Device Name

Extremity CT Imaging System

Manufacturer

Mars Bioimaging , Ltd.

Date Cleared

2026-03-13

(238 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253261

Validate with FDA (Live)

Device Name

Apollo Quattro (APQ-10M)

Manufacturer

Weero Co., Ltd.

Date Cleared

2026-03-13

(165 days)

Product Code

PBX

Regulation Number

878.4400

Type

Traditional

Panel

General & Plastic Surgery

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K252261

Validate with FDA (Live)

Device Name

InferCare RECIST

Manufacturer

Beijing Infervision Healthcare Medical Technology Co., Ltd.

Date Cleared

2026-03-13

(235 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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