SURGICAL INSTRUMENTS— 510(k) K801819

Name: FDA 510(k) clearance K801819
Creator: U.S. Food and Drug Administration
Published: 1980-08-20

Substantially Equivalent

Robert I. Chien & Assoc., Inc.

FDA 510(k) clearance K801819 for SURGICAL INSTRUMENTS, Substantially Equivalent on 1980-08-20. Applicant: Robert I. Chien & Assoc., Inc.. Device class: 1.

Clearance details

Applicant: Robert I. Chien & Assoc., Inc.
Product code: Code HXD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1980-07-31
Decision date: 1980-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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 Robert I. Chien & Assoc., Inc.

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K822151 — SURGICAL INSTRUMENTS REPRESENT. 4 CLASS1982-08-19
K811632 — UNSTERILIZED LAPAROTOMY SPONGES (CHINA)1981-09-11
K811631 — THERMOMETER (MADE IN CHINA)1981-07-20
K810054 — RICA (DIAGNOSTIC INSTRUMENTS)1981-01-28
K801028 — RICA OR SMIC SURGICAL INSTRUMENTS1980-05-20

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.