BIPOLAR ELECTROSURGICAL SNARE— 510(k) K893553

Name: FDA 510(k) clearance K893553
Creator: U.S. Food and Drug Administration
Published: 1989-09-08

Substantially Equivalent

Everest Medical Corp.

FDA 510(k) clearance K893553 for BIPOLAR ELECTROSURGICAL SNARE, Substantially Equivalent on 1989-09-08. Applicant: Everest Medical Corp.. Device class: 2.

Clearance details

Applicant: Everest Medical Corp.
Product code: Code FDI
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 1989-05-08
Decision date: 1989-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn Center, MN, US

Download summary PDF View on FDA.gov ↗

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K220790 — Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare2022-06-27

More clearances from Everest Medical Corp.

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K003060 — PLASMAKINETIC GENERATOR2000-10-31
K000496 — EVERSHEARS BIPOLAR SCISSORS2000-04-24
K993412 — BITX PROBES2000-03-31
K994336 — BITX PROBES2000-02-08
K971565 — BICOAG COAGULATING FORCEPS1998-03-12

Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

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.