Product code FXR— General, Plastic Surgery

SONI-LOK SCOPE STABILIZER

Classification name: Holder, Camera, Surgical
Device class: Class 1
Regulation: 21 CFR 878.4160
Advisory panel: General, Plastic Surgery
Total cleared: 2
First cleared: 1981-02-26
Most recent: 1985-02-21

Market context for product code FXR

FDA has cleared 2 devices under product code FXR between 1981 and 1985, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19851 clearance
19811 clearance

Top applicants under product code FXR

The Anspach Effort, Inc.1 clearance
Med Surg Designs, Inc.1 clearance

Recent clearances under product code FXR

K850122 — SONI-LOK SCOPE STABILIZERMed Surg Designs, Inc.·1985-02-21
K810303 — TELEVISION CAMERA HOLDER FOR SURGERYThe Anspach Effort, Inc.·1981-02-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.