FDA product code HGB: Clip, Tubal Occlusion
HGB is the FDA product code for clip, tubal occlusion. It is a Class III device, regulated under 21 CFR 884.5380 and reviewed by the Obstetrics and Gynecology panel. Devices under HGB reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for HGB devices.
Definition
Call for PMAs 12/30/87 (52 FR 36883 10/1/87))
Classification
| Field | Value |
|---|---|
| Device name | Clip, Tubal Occlusion |
| Device class | Class III |
| Regulation | 21 CFR 884.5380 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
| Implant | Yes |
Recalls for HGB devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-09-04.
Frequently asked questions
What is FDA product code HGB?
HGB is the FDA product code for clip, tubal occlusion. It is a Class III device, regulated under 21 CFR 884.5380 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGB?
Class III, regulation 21 CFR 884.5380. Typical premarket route: PMA.
Have HGB devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2013-09-04.
Next steps
- Run an FDA pathway report with predicate devices for product code HGB
- Run a recall and safety report across every HGB manufacturer
- Watch product code HGB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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