COLOR-EZE PRE-WASHED LAP SPONGES— 510(k) K831913

Name: FDA 510(k) clearance K831913
Creator: U.S. Food and Drug Administration
Published: 1983-09-26

Substantially Equivalent

Ormed Mfg., Inc.

FDA 510(k) clearance K831913 for COLOR-EZE PRE-WASHED LAP SPONGES, Substantially Equivalent on 1983-09-26. Applicant: Ormed Mfg., Inc.. Device class: 1.

Clearance details

Applicant: Ormed Mfg., Inc.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1983-06-14
Decision date: 1983-09-26
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

More clearances from Ormed Mfg., Inc.

view all

K931555 — ARTROMOT K2 CPM1994-01-31
K882527 — GAUZE SPONGE1988-07-18
K882528 — CYLINDRICAL SPONGE1988-07-18
K882529 — BUTCHER STRUNG TONSIL SPONGE1988-07-18
K882530 — TAPE STRUNG TONSIL SPONGE1988-07-18

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.