510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SCBClass II

Deflation Needle For Removal Of Intragastric Balloon

21 CFR 876.1550 / Gastroenterology, Urology
FDA source (opens on fda.gov)

SCB is the FDA product code for Deflation Needle For Removal Of Intragastric Balloon, a class II device type, regulated under 21 CFR 876.1550. FDA's definition for this code reads: "Deflation needle is a prescription use device intended to puncture and drain fluid from an intragastric balloon so that the empty balloon may be removed endoscopically". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SCB
Device name
Deflation Needle For Removal Of Intragastric Balloon
FDA definition
Deflation needle is a prescription use device intended to puncture and drain fluid from an intragastric balloon so that the empty balloon may be removed endoscopically.
Regulation
21 CFR 876.1550
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code SCB.