Question 1

Who is the manufacturer of ARTHROSCOPES & ASSOCIATED INSTRUMENTS?

Accepted Answer

Downs Surgical , Ltd. filed the 510(k) submission for ARTHROSCOPES & ASSOCIATED INSTRUMENTS (K821359).

Question 2

What is the FDA product code for ARTHROSCOPES & ASSOCIATED INSTRUMENTS?

Accepted Answer

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

Question 3

When was ARTHROSCOPES & ASSOCIATED INSTRUMENTS cleared by the FDA?

Accepted Answer

May 27, 1982 (decision: SESE).

Question 4

What is the regulatory pathway for ARTHROSCOPES & ASSOCIATED INSTRUMENTS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ARTHROSCOPES & ASSOCIATED INSTRUMENTS?

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	K821359
Device Name	ARTHROSCOPES & ASSOCIATED INSTRUMENTS
Applicant	Downs Surgical , Ltd.
Product Code	HRX · Orthopedic
Decision Date	May 27, 1982
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2

ARTHROSCOPES & ASSOCIATED INSTRUMENTS

Device Facts

Regulatory Classification

Identification