Question 1

Who is the manufacturer of ARTHROSCOPIC SURGICAL BLADE?

Accepted Answer

Smith & Nephew Dyonics, Inc. filed the 510(k) submission for ARTHROSCOPIC SURGICAL BLADE (K904284).

Question 2

What is the FDA product code for ARTHROSCOPIC SURGICAL BLADE?

Accepted Answer

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

Question 3

When was ARTHROSCOPIC SURGICAL BLADE cleared by the FDA?

Accepted Answer

Dec 5, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for ARTHROSCOPIC SURGICAL BLADE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ARTHROSCOPIC SURGICAL BLADE?

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	K904284
Device Name	ARTHROSCOPIC SURGICAL BLADE
Applicant	Smith & Nephew Dyonics, Inc.
Product Code	HRX · Orthopedic
Decision Date	Dec 5, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2

ARTHROSCOPIC SURGICAL BLADE

Device Facts

Regulatory Classification

Identification