Question 1

Who is the manufacturer of PROBE?

Accepted Answer

Plastafil, Inc. filed the 510(k) submission for PROBE (K841624).

Question 2

What is the FDA product code for PROBE?

Accepted Answer

HRX. It is classified under 21 CFR 888.1100 as a Class 2 device in the Orthopedic panel.

Question 3

When was PROBE cleared by the FDA?

Accepted Answer

Aug 27, 1984 (decision: SESE).

Question 4

What is the regulatory pathway for PROBE?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like PROBE?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K841624
Device Name	PROBE
Applicant	Plastafil, Inc.
Product Code	HRX · Orthopedic
Decision Date	Aug 27, 1984
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2

PROBE

Device Facts

Regulatory Classification

Identification