ENDO-SPONGE— 510(k) K892218

Name: FDA 510(k) clearance K892218
Creator: U.S. Food and Drug Administration
Published: 1989-05-31

Substantially Equivalent

Endovations

FDA 510(k) clearance K892218 for ENDO-SPONGE, Substantially Equivalent on 1989-05-31. Applicant: Endovations. Device class: 1.

Clearance details

Applicant: Endovations
Product code: Code MNL
Device class: Class 1
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1989-04-03
Decision date: 1989-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mechanicsburg, PA, US

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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

Adverse events under product code MNL

product code MNL

Malfunction: 443
Total: 443

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.