LAPARATOMY SPONGE— 510(k) K781818

Name: FDA 510(k) clearance K781818
Creator: U.S. Food and Drug Administration
Published: 1978-11-15

Substantially Equivalent

Meden Medical Sales Division

FDA 510(k) clearance K781818 for LAPARATOMY SPONGE, Substantially Equivalent on 1978-11-15. Applicant: Meden Medical Sales Division. Device class: 1.

Clearance details

Applicant: Meden Medical Sales Division
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1978-10-27
Decision date: 1978-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDY

view all

K972634 — ULTRACELL SUCTION SPONGE1997-12-17
K960236 — CPR LAP SPONGES1996-03-28
K955599 — STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE1996-02-22
K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE1995-12-19
K953830 — KENSORB1995-10-03

Adverse events under product code GDY

product code GDY

Malfunction: 764
Total: 764

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.