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Lithotripsy Probe 1.9FR 250cm

FDA UDI

Class II (US FDA UDI)

by Northgate Technologies Inc.

Identity

Trade Name
Lithotripsy Probe 1.9FR 250cm FDA UDI
Generic Name
Electrohydraulic/pneumatic lithotripsy system probe, salivary, single-use FDA UDI
Device Name
1.9FR 250cm Lithotripsy Probe for use with Autolith Lithotripters FDA UDI
Model / Reference
9-195-25 FDA UDI
Description
1.9FR 250cm Lithotripsy Probe for use with Autolith Lithotripters FDA UDI

Identifiers

Primary DI / UDI-DI
00817183020134 FDA UDI
510(k) Number
K914514 FDA UDI
FDA Product Code
FFK FDA UDI
GMDN Term
Electrohydraulic/pneumatic lithotripsy system probe, salivary, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4480 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

Yes

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

Yes

FDA UDI

Category: Electrohydraulic/pneumatic lithotripsy system probe, salivary, single-use

Lithotripsy Probe 1.9FR 250cm by Northgate Technologies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrohydraulic/pneumatic lithotripsy system probe, salivary, single-use.

Cleared under the same submission

K914514 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Northgate Technologies Inc.

Sources (1)

  • FDA UDI d03be2f1-c4b3-4544-a391-3796742cd092 34 fields · synced May 30, 2026