MANUAL INSTRUMENTS— 510(k) K943937

Substantially Equivalent

Pantheon Surgical Products

FDA 510(k) clearance K943937 for MANUAL INSTRUMENTS, Substantially Equivalent on 1995-03-06. Applicant: Pantheon Surgical Products.

Clearance details

Applicant: Pantheon Surgical Products
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1994-08-12
Decision date: 1995-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lowell, MA, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.