Camera Enabled Probe

FDA 510(k) K141119 · Trice Medical, Inc.

Substantially Equivalent

510(k) numberK141119

Submission

Device name
Camera Enabled Probe
Applicant
Trice Medical, Inc.
King Of Prussia, PA, US
Received
April 30, 2014
Decision date
July 29, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HRX – Arthroscope
Device class
Class II (moderate risk)
Regulation
21 CFR 888.1100
Specialty
Orthopedic

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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K252666Articulator Arthroscopic BurHRX · Traditional Joint Preservation Innovations, LLC11/21/2025SE
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Questions and answers

When was Camera Enabled Probe cleared by the FDA?

Camera Enabled Probe (K141119) received a 510(k) decision of Substantially Equivalent on July 29, 2014, 90 days after the submission was received.

What is the product code of K141119?

The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.