Delphi System

FDA UDI

Class II (US FDA UDI)

by Cs Medical Llc

Identity

Trade Name: DELPHI SYSTEM FDA UDI
Generic Name: Electrosurgical system generator FDA UDI
Device Name: DELPHI II (Generator) FDA UDI
Model / Reference: DP2000 FDA UDI
Description: DELPHI II (Generator) FDA UDI

Identifiers

Primary DI / UDI-DI: 08800267437999 FDA UDI
510(k) Number: K242907 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Electrosurgical system generator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrosurgical system generator

Delphi System by Cs Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Electrosurgical system generator.

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WEREWOLF — Smith & Nephew, Inc. · Class II
PerFect TCS — Coltene/Whaledent Inc. · Class II
INTELLIO SHIFT — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K242907 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

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Manufacturer

Manufacturer: Cs Medical Llc

Sources (1)

FDA UDI 1efcd315-fd71-4efd-821d-9e0116e5550a 35 fields · synced May 30, 2026