BAHO AUTOCLAVABLE LAPAROSCOPE— 510(k) K982276

Substantially Equivalent

Microptix Int'L, LLC

FDA 510(k) clearance K982276 for BAHO AUTOCLAVABLE LAPAROSCOPE, Substantially Equivalent on 1999-02-18. Applicant: Microptix Int'L, LLC.

Clearance details

Applicant: Microptix Int'L, LLC
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1998-06-29
Decision date: 1999-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Haven, CT, US

Download summary PDF View on FDA.gov ↗

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.