510(k) K926585

THOROCOSCOPY SELF-RETAINING RETRACTOR by T. Korossurgical Instruments Corp. — Product Code GAD

K926585 is an FDA 510(k) premarket notification submitted by T. Korossurgical Instruments Corp. for the device "THOROCOSCOPY SELF-RETAINING RETRACTOR". The FDA issued a decision of Substantially Equivalent on August 6, 1993. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. T. Korossurgical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1993
Date Received
September 18, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type