CARASYN HYDROGEL WOUND PRODUCTS— 510(k) K961758

Substantially Equivalent for Some Indications

Carrington Laboratories, Inc.

FDA 510(k) clearance K961758 for CARASYN HYDROGEL WOUND PRODUCTS, Substantially Equivalent for Some Indications on 1996-07-11. Applicant: Carrington Laboratories, Inc..

Clearance details

Applicant: Carrington Laboratories, Inc.
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1996-05-03
Decision date: 1996-07-11
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Irving, TX, US

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Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

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.