BIOPSY FORCEPS, (NON-RIGID)— 510(k) K896146

Name: FDA 510(k) clearance K896146
Creator: U.S. Food and Drug Administration
Published: 1990-03-09

Substantially Equivalent

Portlyn Corp.

FDA 510(k) clearance K896146 for BIOPSY FORCEPS, (NON-RIGID), Substantially Equivalent on 1990-03-09. Applicant: Portlyn Corp.. Device class: 2.

Clearance details

Applicant: Portlyn Corp.
Product code: Code EOQ
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 1989-10-23
Decision date: 1990-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moultonboro, NH, US

Download summary PDF View on FDA.gov ↗

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K951447 — DYNABITE CARDIOVASCULAR BIOPSY FORCEPS1995-07-27
K952391 — DYNABITE UROLOGICAL FORCEPS1995-06-01
K944245 — DYNABITE LAPAROSCOPIC FORCEPS1994-11-15
K934506 — DYNABITE HYSTEROSCOPIC FORCEPS1994-03-22

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.