510(k) K962032

KARL STORZ TWIN TRANSILLUMINATOR by KARL STORZ Endoscopy-America, Inc. — Product Code MQW

K962032 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ TWIN TRANSILLUMINATOR". The FDA issued a decision of Substantially Equivalent on July 5, 1996. The device falls under product code MQW (Transilluminator, Fiber Optic), a Class I device regulated under 21 CFR 874.4350. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1996
Date Received
May 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transilluminator, Fiber Optic
Device Class
Class I
Regulation Number
874.4350
Review Panel
EN
Submission Type