Question 1

Who is the manufacturer of ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA?

Accepted Answer

Acufex Microsurgical, Inc. filed the 510(k) submission for ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA (K942834).

Question 2

What is the FDA product code for ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA?

Accepted Answer

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

Question 3

When was ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA cleared by the FDA?

Accepted Answer

Sep 28, 1994 (decision: SESE).

Question 4

What is the regulatory pathway for ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA?

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	K942834
Device Name	ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA
Applicant	Acufex Microsurgical, Inc.
Product Code	HRX · Orthopedic
Decision Date	Sep 28, 1994
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2

ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA

Device Facts

Regulatory Classification

Identification