Who is the manufacturer of E-Z LOOP?

John F. Greer Co., Inc. filed the 510(k) submission for E-Z LOOP (K870577).

What is the FDA product code for E-Z LOOP?

EXB. It is classified under 21 CFR 876.5900 as a Class 1 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for E-Z LOOP?

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

Who can help prepare an FDA 510(k) submission like E-Z LOOP?

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.

E-Z LOOP

K870577 · John F. Greer Co., Inc. · EXB · Apr 17, 1987 · Gastroenterology, Urology

Device Facts

Record ID	K870577
Device Name	E-Z LOOP
Applicant	John F. Greer Co., Inc.
Product Code	EXB · Gastroenterology, Urology
Decision Date	Apr 17, 1987
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5900
Device Class	Class 1

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