Atlas FDA

HGH

6 FDA 510(k) clearances · Product code

266 daysmedian time to decision
421 days90th percentile
6clearances measured

FDA profile

Official device name
Cannula, Suction, Uterine
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5070
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
1999: 1 · 2002: 2 · 2010: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Hysteroscopy System (K172151)Chongquin Jinshan Science & Technology (Group) Co., Ltd.2018-04-09
PANPAC DISPOSABLE VACUUM CURETTES (K161106)Panpac Medical Corporation2017-01-13
DISPOSABLE ENDOSCOPIC CANNULA (K140213)Dongguan Microview Medical Technology Co., Ltd.2015-03-25
RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) (K093508)Womancare Global2010-03-04
KOLSTER METHODS (K935820)Kolster Methods1994-07-19
NON STRESS TEST MONITOR 507 (K840285)Imex Medical Systems, Inc.1984-05-09

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Every clearance here is in the API, with alerts when new ones post.