TRAUMA TABLE— 510(k) K853535

Name: FDA 510(k) clearance K853535
Creator: U.S. Food and Drug Administration
Published: 1985-09-11

Substantially Equivalent

Xre Corp.

FDA 510(k) clearance K853535 for TRAUMA TABLE, Substantially Equivalent on 1985-09-11. Applicant: Xre Corp.. Device class: 1.

Clearance details

Applicant: Xre Corp.
Product code: Code GDC
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 1985-08-23
Decision date: 1985-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, MA, US

Download summary PDF View on FDA.gov ↗

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K964273 — DURA-BOARD ARMBOARD1997-01-08
K940616 — SKYTRON ELITE 3500 TABLE1994-06-13
K934744 — MIDMARK MAGNUM GENERAL SURGICAL TABLE1994-03-28

More clearances from Xre Corp.

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K973744 — UNICATH SP BI-PLANE (MODEL M269 & M289)1997-12-29
K961193 — FULL FRAME ZOOM SYSTEM1996-06-17
K960998 — XRE COLLIMATOR1996-04-03
K945449 — UNICATH LLU ANGIOGRAPHIC SYSTEM1995-02-27
K936002 — CINEMAC QAS1994-09-09

Adverse events under product code GDC

product code GDC

Malfunction: 791
Total: 791

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.