STEERABLE CATHETER SYSTEM— 510(k) K862424

Substantially Equivalent

Endovations

FDA 510(k) clearance K862424 for STEERABLE CATHETER SYSTEM, Substantially Equivalent on 1986-09-22. Applicant: Endovations. Device class: 2.

Clearance details

Applicant: Endovations
Product code: Code GCP
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1986-06-26
Decision date: 1986-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camp Hill, PA, US

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K860103 — MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE1986-02-12
K843683 — MODULAR FIBERSCOPE SYSTEM1985-01-18

More clearances from Endovations

K955413 — ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER1996-02-08
K942110 — INJECT-SNARE1994-10-13
K934315 — ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME1994-02-28
K913841 — 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH1991-10-08
K913870 — 5MM MICROSCISSORS1991-09-16

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