Question 1

Who is the manufacturer of DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION?

Accepted Answer

Smith & Nephew Dyonics, Inc. filed the 510(k) submission for DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION (K934299).

Question 2

What is the FDA product code for DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION?

Accepted Answer

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

Question 3

When was DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION cleared by the FDA?

Accepted Answer

Feb 14, 1994 (decision: SESE).

Question 4

What is the regulatory pathway for DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION?

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	K934299
Device Name	DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION
Applicant	Smith & Nephew Dyonics, Inc.
Product Code	HRX · Orthopedic
Decision Date	Feb 14, 1994
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2

DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION

Device Facts

Regulatory Classification

Identification