510(k) K926335

IDEAS PEANUT WAND by Ideal Medical, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1993
Date Received
December 16, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, General & Plastic Surgery
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).