ENDOSCOPIC SCLEROTHERAPY BALLOON— 510(k) K821999

Substantially Equivalent

Retech

FDA 510(k) clearance K821999 for ENDOSCOPIC SCLEROTHERAPY BALLOON, Substantially Equivalent on 1982-08-27. Applicant: Retech. Device class: 2.

Clearance details

Applicant: Retech
Product code: Code GCP
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1982-07-07
Decision date: 1982-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GCP

K954614 — EOS BRAND DISPOSABLE PROCTOSCOPE1996-04-10
K896505 — PORGES UNIVERSAL HANDLES1990-01-30
K896008 — MODEL 6500 MERCURY ARC LIGHT SOURCE1989-12-27
K862424 — STEERABLE CATHETER SYSTEM1986-09-22
K860103 — MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE1986-02-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.