ESPI CLAW FORCEP, #8301, 5MM, 30 CM LENGTH— 510(k) K903592

Name: FDA 510(k) clearance K903592
Creator: U.S. Food and Drug Administration
Published: 1990-09-12

Substantially Equivalent

Dixon Medical, Inc.

FDA 510(k) clearance K903592 for ESPI CLAW FORCEP, #8301, 5MM, 30 CM LENGTH, Substantially Equivalent on 1990-09-12. Applicant: Dixon Medical, Inc.. Device class: 2.

Clearance details

Applicant: Dixon Medical, Inc.
Product code: Code HET
Device class: Class 2
Regulation: 21 CFR 884.1720
Advisory panel: Obstetrics/Gynecology
Date received: 1990-08-08
Decision date: 1990-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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K903598 — ESPI DOUBLE-ACTION GRASPER, INSULATED, #8202-N1990-10-17
K903599 — ESPI DOUBLE-ACTION INSULATED GRASPER, #8203-N1990-10-17
K903600 — ESPI MICRO GRASPER,DOUBLE-ACTION,INSULATED,#8250-N1990-10-17
K903591 — ESPI HOOK/UNIVERSAL SCISSORS, # 81011990-09-12
K903593 — ESPI APPLICATOR SLEEVE, #84101990-09-12

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.