MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE— 510(k) K860103

Name: FDA 510(k) clearance K860103
Creator: U.S. Food and Drug Administration
Published: 1986-02-12

Substantially Equivalent

Endotherapeutics

FDA 510(k) clearance K860103 for MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE, Substantially Equivalent on 1986-02-12. Applicant: Endotherapeutics. Device class: 2.

Clearance details

Applicant: Endotherapeutics
Product code: Code GCP
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1986-01-10
Decision date: 1986-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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K870855 — UROSCAN1987-06-09
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K860102 — MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE1986-02-12
K852031 — ENDOPORT 5MM1985-08-13
K844619 — ENDONEEDLE1985-01-09

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