SUCTION TUBE— 510(k) K864770

Name: FDA 510(k) clearance K864770
Creator: U.S. Food and Drug Administration
Published: 1987-02-24

Substantially Equivalent

New England Surgical Instrument Corp.

FDA 510(k) clearance K864770 for SUCTION TUBE, Substantially Equivalent on 1987-02-24. Applicant: New England Surgical Instrument Corp.. Device class: 2.

Clearance details

Applicant: New England Surgical Instrument Corp.
Product code: Code FFA
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1986-12-05
Decision date: 1987-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

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K895331 — ELECTROSURGICAL ELECTRODE1989-09-15
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K883963 — RANEY AND LEROY-RANEY SCALP CLIP1988-10-07
K883396 — HANDSWITCHING MONOPOLAR PENCIL1988-09-13
K880863 — BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-12001988-04-19

Adverse events under product code FFA

product code FFA

Death: 3
Total: 3

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.