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Signature

FDA UDI

Class II (US FDA UDI)

by Silex Medical, Llc

Identity

Trade Name
Signature FDA UDI
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Device Name
Hunter Style Bowel Grasping Forceps FDA UDI
Model / Reference
5851093 FDA UDI
Description
Hunter Style Bowel Grasping Forceps FDA UDI

Identifiers

Primary DI / UDI-DI
B3315851093 FDA UDI
510(k) Number
K914910 FDA UDI
K933387 FDA UDI
K946263 FDA UDI
FDA Product Code
GEI FDA UDI
GCJ FDA UDI
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
876.1500 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Rigid endoscopic tissue manipulation forceps, reusableEndoscopic electrosurgical handpiece/electrode, monopolar, reusable

Signature by Silex Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical handpiece/electrode, monopolar, reusable.

Cleared under the same submission

K914910 also covers:

K933387 also covers:

K946263 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Silex Medical, Llc

Sources (1)

  • FDA UDI 47c86170-7ec3-4569-b010-8dce32ae228b 34 fields · synced May 30, 2026