510(k) K981717

STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR by Stryker Instruments — Product Code FTD

K981717 is an FDA 510(k) premarket notification submitted by Stryker Instruments for the device "STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR". The FDA issued a decision of Substantially Equivalent on June 30, 1998. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580. Stryker Instruments has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1998
Date Received
May 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Surgical
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type