510(k) K950125

KARL STORZ BOUGIES AND DILATORS by KARL STORZ Endoscopy-America, Inc. — Product Code FAX

K950125 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ BOUGIES AND DILATORS". The FDA issued a decision of Substantially Equivalent on February 7, 1995. The device falls under product code FAX (Bougie, Urological), a Class I device regulated under 21 CFR 876.5520. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.