EXUSORB(TM) DRY/WET DRESSING— 510(k) K896176

Name: FDA 510(k) clearance K896176
Creator: U.S. Food and Drug Administration
Published: 1989-11-24

Substantially Equivalent

Controlled Therapeutics Corp.

FDA 510(k) clearance K896176 for EXUSORB(TM) DRY/WET DRESSING, Substantially Equivalent on 1989-11-24. Applicant: Controlled Therapeutics Corp.. Device class: 1.

Clearance details

Applicant: Controlled Therapeutics Corp.
Product code: Code KOZ
Device class: Class 1
Regulation: 21 CFR 878.4018
Advisory panel: General, Plastic Surgery
Date received: 1989-10-25
Decision date: 1989-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOZ

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K905206 — INCARE PINSITE DRESSING1991-04-12
K905688 — CUTINOVA HYDRO1991-04-01
K905069 — IODOSORB GEL1991-01-31
K904604 — REDI-RELEASE ABSORBENT DRESSING1991-01-07
K896828 — BIOCLUSIVE(R) ABSORBENT DRESSING1990-11-21

More clearances from Controlled Therapeutics Corp.

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K895606 — EXUSORB(TM) GEL DRESSING1989-10-19
K894996 — EXUSORB(TM) GRANULES1989-09-28
K894274 — EXUSORB TRANSPARENT DRESSING1989-08-18

Adverse events under product code KOZ

product code KOZ

Other: 1
Total: 1

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.