KENDALL UNIVERSAL EXTENSION SET— 510(k) K930551

Name: FDA 510(k) clearance K930551
Creator: U.S. Food and Drug Administration
Published: 1993-05-12

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

FDA 510(k) clearance K930551 for KENDALL UNIVERSAL EXTENSION SET, Substantially Equivalent on 1993-05-12. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health. Device class: 1.

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code GBX
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1993-02-03
Decision date: 1993-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)1997-12-15
K973619 — KENDALL CURITY NON-ADHERING DRESSING1997-12-10
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Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.