ENVICLUSIVE (TM)— 510(k) K874554

Name: FDA 510(k) clearance K874554
Creator: U.S. Food and Drug Administration
Published: 1988-03-11

Substantially Equivalent

Marion Laboratories, Inc.

FDA 510(k) clearance K874554 for ENVICLUSIVE (TM), Substantially Equivalent on 1988-03-11. Applicant: Marion Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Marion Laboratories, Inc.
Product code: Code NAD
Device class: Class 1
Regulation: 21 CFR 878.4020
Advisory panel: General, Plastic Surgery
Date received: 1987-11-04
Decision date: 1988-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NAD

view all

K254246 — LT Antibacterial Foam with Silver Dressing2026-09-10
K102403 — SAM CHEST SEAL WITH VAVLE2011-03-03
K091133 — APLION TOPICAL CARE SYSTEM2009-05-20
K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)2008-06-17
K080524 — CENTURION SORBAVIEW OTC2008-04-23

More clearances from Marion Laboratories, Inc.

view all

K883391 — POLYMER ADHESIVE BANDAGE1989-03-23
K875182 — MODIFIED LABELING FOR TOXI-LAB THC SCREEN1988-07-05
K875181 — MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM1988-05-27
K874551 — ENVINET(TM)1988-01-22
K874552 — ENVISAN PAD1988-01-22

Adverse events under product code NAD

product code NAD

Injury: 431
Malfunction: 11,935
Other: 1
Total: 12,367

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.