Question 1

Who is the manufacturer of CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES?

Accepted Answer

Smith & Nephew, Inc. filed the 510(k) submission for CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES (K941036).

Question 2

What is the FDA product code for CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES?

Accepted Answer

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

Question 3

When was CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES cleared by the FDA?

Accepted Answer

Sep 28, 1994 (decision: SESE).

Question 4

What is the regulatory pathway for CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES?

Accepted Answer

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

Question 5

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

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	K941036
Device Name	CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES
Applicant	Smith & Nephew, Inc.
Product Code	HRX · Orthopedic
Decision Date	Sep 28, 1994
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2

CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES

Device Facts

Regulatory Classification

Identification