JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT— 510(k) K852297

Name: FDA 510(k) clearance K852297
Creator: U.S. Food and Drug Administration
Published: 1985-06-12

Substantially Equivalent

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K852297 for JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT, Substantially Equivalent on 1985-06-12. Applicant: Johnson & Johnson Professionals, Inc.. Device class: 1.

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code EXB
Device class: Class 1
Regulation: 21 CFR 876.5900
Advisory panel: Gastroenterology, Urology
Date received: 1985-05-29
Decision date: 1985-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXB

view all

K252140 — Heylo System2025-10-06
K181643 — SmartBag (SmartPouch)2018-11-16
K140938 — OSTOM-I ALERT2014-10-10
K922730 — LAKE OSTOMY CARE SET1993-12-30
K882878 — ODOR-END EMERGENCY CLEAN UP POWDER1988-12-08

More clearances from Johnson & Johnson Professionals, Inc.

view all

K992173 — SIPHONGUARD CSF CONTROL DEVICE2000-04-07
K991413 — CODMAN ETHISORB DURA PATCH2000-03-13
K991222 — CODMAN MICROSENSOR VENTRICULAR CATHETER KIT1999-07-09
K982379 — SUNDT SLIM-LINE ANEURYSM CLIP APPLIER1998-12-18
K982812 — G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)1998-12-04

Adverse events under product code EXB

product code EXB

Injury: 145
Total: 145

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.