EP-100 (SERIES)— 510(k) K884415

Name: FDA 510(k) clearance K884415
Creator: U.S. Food and Drug Administration
Published: 1989-02-28

Substantially Equivalent

Stereotactic Medical Systems, Inc.

FDA 510(k) clearance K884415 for EP-100 (SERIES), Substantially Equivalent on 1989-02-28. Applicant: Stereotactic Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Stereotactic Medical Systems, Inc.
Product code: Code FPD
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1988-10-20
Decision date: 1989-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Valley City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FPD

view all

K243361 — Nutrifit2024-12-19
K180236 — VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)2019-01-18
K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE2013-10-23
K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE2013-03-06
K121105 — NUTRISAFE 2 FEEDING TUBE2012-12-18

More clearances from Stereotactic Medical Systems, Inc.

view all

K896156 — COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM1989-12-06
K883653 — EP-100 INFUSION PUMP1988-11-01
K871046 — COMPASS STEREOTACTIC POSITIONING SYSTEM1987-05-08
K862220 — COMPASS CT STEREOTACTIC ADAPTATION SYSTEM1986-06-18

Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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