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

HODGE TUBE

K Number: K772282 · Decision Mar 9, 1978
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
12
Applicant Total
92
Review Days
87

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Basic Information

Device Name
HODGE TUBE
K Number
K772282
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.5980
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Applicant
Mallinckrodt Critical Care
Date Received
December 12, 1977
Decision Date
March 9, 1978
Product Code
FEG
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
GU
Third Party
N

Classifications

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

Product Code Device Name
FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation

Similar 510(k) Clearances

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Other Clearances by Mallinckrodt Critical Care

K Number Device Name
K880343 BURNEY GALLBLADDER CATHETER KIT
K874605 HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR
K874514 HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE
K874568 HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR
K874404 HI-LO TEMP(R) SKIN TEMPERATURE SENSOR
K873461 LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)
K873833 THERMOCOUPLE ADAPTER
K873004 GUIDING CATHETER
K871204 CUFFED TRACHEAL TUBE (MULTIPLE)
K862666 UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
Search all 92 clearances from Mallinckrodt Critical Care →