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Bipolar Scissor

FDA UDI

Class II (US FDA UDI)

by Soniquence, LLC

Identity

Trade Name
Bipolar Scissor FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Device Name
Bipolar Scissor (Crv.) 7" (18cm), Reusable FDA UDI
Model / Reference
SBPSC08 FDA UDI
Description
Bipolar Scissor (Crv.) 7" (18cm), Reusable FDA UDI

Identifiers

Catalog Number
SBPSC08 FDA UDI
Primary DI / UDI-DI
00810026180538 FDA UDI
510(k) Number
K042608 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Bipolar Scissor by Soniquence, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, reusable.

Cleared under the same submission

K042608 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Soniquence, LLC

Sources (1)

  • FDA UDI f19a76ae-1768-4a06-a281-6649d71ebe10 35 fields · synced Jun 8, 2026