Question 1

Who is the manufacturer of INTRA-ARTICULAR SHAVER?

Accepted Answer

Dyonics, Inc. filed the 510(k) submission for INTRA-ARTICULAR SHAVER (K771218).

Question 2

What is the FDA product code for INTRA-ARTICULAR SHAVER?

Accepted Answer

KIJ. It is classified under 21 CFR 878.4820 as a Class 1 device in the General, Plastic Surgery panel.

Question 3

When was INTRA-ARTICULAR SHAVER cleared by the FDA?

Accepted Answer

Feb 1, 1978 (decision: SESE).

Question 4

What is the regulatory pathway for INTRA-ARTICULAR SHAVER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like INTRA-ARTICULAR SHAVER?

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	K771218
Device Name	INTRA-ARTICULAR SHAVER
Applicant	Dyonics, Inc.
Product Code	KIJ · General, Plastic Surgery
Decision Date	Feb 1, 1978
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4820
Device Class	Class 1

INTRA-ARTICULAR SHAVER

Device Facts

Regulatory Classification

Identification