FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

CERULLO SUCTION REGULATOR

K Number: K880704 · Decision Mar 29, 1988
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
13
Review Days
36

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
CERULLO SUCTION REGULATOR
K Number
K880704
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.6740
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Aesculap Instruments Corp.
Date Received
February 22, 1988
Decision Date
March 29, 1988
Product Code
GCX
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (GCX), ordered by most recent decision date.

View all

Other Clearances by Aesculap Instruments Corp.

K Number Device Name
K885046 INSITUCAT VALVE STRIPPER
K890182 PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV
K890443 CASPAR SCALP CLIP, APPLIER
K893121 ROBOTRAC (TM) RETRACTOR ARM
K884057 ELAN-E DISPOSABLE DRAPE
K860016 AESCULAP BONE MILL
K801888 HANDPIECE, DENTAL
K801886 BURR, DENTAL
K801887 DRILL, DENTAL
K792558 CONTAINER SYSTEM
Search all 13 clearances from Aesculap Instruments Corp. →