ACCESS SURGICAL BIPOLAR ENDOSCOPIC SURG. INSTRUM.— 510(k) K922423

Name: FDA 510(k) clearance K922423
Creator: U.S. Food and Drug Administration
Published: 1992-11-18

Substantially Equivalent

Access Surgical Intl., Inc.

FDA 510(k) clearance K922423 for ACCESS SURGICAL BIPOLAR ENDOSCOPIC SURG. INSTRUM., Substantially Equivalent on 1992-11-18. Applicant: Access Surgical Intl., Inc.. Device class: 2.

Clearance details

Applicant: Access Surgical Intl., Inc.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1992-05-21
Decision date: 1992-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedminster, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Access Surgical Intl., Inc.

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K954536 — BLADE, SCALPEL & BLADE, HANDEL1995-11-29
K953376 — ACCESS POINT1995-09-12
K945545 — ACCESS SURGICAL INT'L THORACIC ENDOSCOPIC SURGICAL INSTRUMENTS1995-01-12
K944974 — ACCESS POINT1994-11-08
K940587 — FLEX-I-PORT1994-03-29

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.