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Signature

FDA UDI

Class II (US FDA UDI)

by Silex Medical, Llc

Identity

Trade Name
Signature FDA UDI
Generic Name
Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
Device Name
Tissue Grasping Forceps FDA UDI
Model / Reference
5851001 FDA UDI
Description
Tissue Grasping Forceps FDA UDI

Identifiers

Primary DI / UDI-DI
B3315851001 FDA UDI
510(k) Number
K914910 FDA UDI
K933387 FDA UDI
K946263 FDA UDI
FDA Product Code
GCJ FDA UDI
GEI FDA UDI
GMDN Term
Rigid endoscopic tissue manipulation forceps, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
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

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 ac287e4e-d2eb-4963-8118-3099724717a6 34 fields · synced Jun 8, 2026