K811961Substantially Equivalent

Visitec Needle Range (Orthopaedic)

Name: K811961 Visitec Needle Range (Orthopaedic)
Creator: Visitec Co.
Published: 1981-07-20
License: https://open.fda.gov/license/

Visitec Co., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K811961 is the FDA 510(k) clearance record for VISITEC NEEDLE RANGE (ORTHOPAEDIC), cleared for Visitec Co. on 1981-07-20. FDA records list 49 510(k) clearances for Visitec Co., from 1979-02-12 to 1995-10-12. As of 2026-09-10, FDA records show no recalls naming K811961.

Clearance record

Decision date: 1981-07-20
Received: 1981-07-10 (10 days to decision)
Review panel: Unknown
Applicant: Visitec Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No