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Reprocessed Colorado Microdissect Needle, 90 Deg Angle

FDA UDI

Class II (US FDA UDI)

by Suretek Medical

Identity

Trade Name
Reprocessed Colorado Microdissect Needle, 90 Deg Angle FDA UDI
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, reprocessed FDA UDI
Model / Reference
N117A FDA UDI

Identifiers

Primary DI / UDI-DI
B390N117A1 FDA UDI
510(k) Number
K052692 FDA UDI
FDA Product Code
NUJ FDA UDI
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, reprocessed 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reprocessed

Reprocessed Colorado Microdissect Needle, 90 Deg Angle by Suretek Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K052692 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Suretek Medical

Sources (1)

  • FDA UDI 2079c137-799b-4486-922f-39ddfc7eaf33 33 fields · synced Jun 8, 2026