510(k) K911262

DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER by ETHICON, Inc. — Product Code GEA

K911262 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER". The FDA issued a decision of Substantially Equivalent on June 20, 1991. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. ETHICON, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1991
Date Received
March 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type