OMNIMED CLAMP— 510(k) K851654

Name: FDA 510(k) clearance K851654
Creator: U.S. Food and Drug Administration
Published: 1985-05-31

Substantially Equivalent

Omni Intl., Inc.

FDA 510(k) clearance K851654 for OMNIMED CLAMP, Substantially Equivalent on 1985-05-31. Applicant: Omni Intl., Inc.. Device class: 1.

Clearance details

Applicant: Omni Intl., Inc.
Product code: Code HXD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1985-04-22
Decision date: 1985-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Springs, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HXD

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K890368 — KIDNEY CLAMP1989-02-03
K890371 — INTESTINAL CRUSHING CLAMP1989-02-03
K890372 — INTESTINAL CLAMP1989-02-03
K890381 — PARAMETRIUM CLAMP1989-02-03
K874959 — VASCULAR CLAMP1987-12-30

More clearances from Omni Intl., Inc.

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K984066 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM1999-01-13
K984064 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE1999-01-08
K853255 — OMNIMED I.V. SOLUTION ADMIN. SET1985-08-23
K851938 — OMNIMED SURGICAL GOWN1985-06-28
K851734 — OMNIMED SUPERIOR TRANSDUCER PROTECTOR1985-05-23

Adverse events under product code HXD

product code HXD

Malfunction: 660
Total: 660

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.