510(k) K942677

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

July 21, 1994

Date Received

June 7, 1994

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Laparoscopy Kit

Device Class

Class II

Regulation Number

876.1500

Review Panel

GU

Submission Type

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.