SOFTTOUCH II LANCET DEVICE— 510(k) K931258

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K931258 for SOFTTOUCH II LANCET DEVICE, Substantially Equivalent on 1994-02-10. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 1993-03-12
Decision date: 1994-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.