Question 1

Who is the manufacturer of SCLERAL BUCKLING IMPLANTS DIF/TYPES?

Accepted Answer

Storz Instrument Co. filed the 510(k) submission for SCLERAL BUCKLING IMPLANTS DIF/TYPES (K832481).

Question 2

What is the FDA product code for SCLERAL BUCKLING IMPLANTS DIF/TYPES?

Accepted Answer

HQX. It is classified under 21 CFR 886.3340 as a Class 2 device in the Ophthalmic panel.

Question 3

When was SCLERAL BUCKLING IMPLANTS DIF/TYPES cleared by the FDA?

Accepted Answer

Sep 20, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for SCLERAL BUCKLING IMPLANTS DIF/TYPES?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SCLERAL BUCKLING IMPLANTS DIF/TYPES?

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	K832481
Device Name	SCLERAL BUCKLING IMPLANTS DIF/TYPES
Applicant	Storz Instrument Co.
Product Code	HQX · Ophthalmic
Decision Date	Sep 20, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.3340
Device Class	Class 2

SCLERAL BUCKLING IMPLANTS DIF/TYPES

Device Facts

Regulatory Classification

Identification