Single Use Micro Electrode (Brass with gold plated shaft) +1 more model

FDA 510(k)

Class II (US FDA 510(k))

510(k) K163442

by Modern Medical Equipment Manufacturing Limited

Identifiers

510(k) Number: K163442 FDA 510(k)
FDA Product Code: GEI FDA 510(k)
Models / Variants: Single Use Micro Electrode (Brass with gold plated shaft) FDA 510(k)
Single Use Micro Electrode (Stainless Steel shaft) FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4400 FDA 510(k)
Regulation Number: 878.4400 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Single Use Micro Electrode (Brass with gold plated shaft) +1 more model by Modern Medical Equipment Manufacturing Limited — Class II — FDA_510K — listed in…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K163442	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Modern Medical Equipment Manufacturing Limited

Sources (1)

FDA 510(k) K163442 24 fields · synced Jun 18, 2026