FAX · Class I · 21 CFR 876.5520

FDA Product Code FAX: Bougie, Urological

Leading manufacturers include Parker Laboratories, Inc. and KARL STORZ Endoscopy-America, Inc..

2
Total
2
Cleared
42d
Avg days
1982
Since

FDA 510(k) Cleared Bougie, Urological Devices (Product Code FAX)

2 devices
1–2 of 2
Cleared Feb 07, 1995
KARL STORZ BOUGIES AND DILATORS
K950125
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 26d
Cleared Nov 03, 1982
ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL
K822711
Parker Laboratories, Inc.
Gastroenterology & Urology · 57d

About Product Code FAX - Regulatory Context