FDA product code · Obstetrics and gynecology
Transcervical Contraceptive Tubal Occlusion Device
1 FDA decision since 2002. No recall names this code.
Call for PMAs 12/30/87 (52 FR 36883 10/1/87))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of HHS at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · HHS
2in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HHS
Too few HHS 510(k)s in any year since 2007 to give a median.
Recalls per year · HHS
No recall names HHS since 2007.
Adverse event reports per year · HHS
749in 2025
MAUDE reports naming product code HHS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 25 |
| 2008 | 4 | — | 0 | 56 |
| 2009 | 7 | — | 0 | 133 |
| 2010 | 2 | — | 0 | 126 |
| 2011 | 2 | — | 0 | 113 |
| 2012 | 7 | — | 0 | 153 |
| 2013 | 1 | — | 0 | 800 |
| 2014 | 1 | — | 0 | 2,237 |
| 2015 | 2 | — | 0 | 5,956 |
| 2016 | 5 | — | 0 | 4,928 |
| 2017 | 1 | — | 0 | 11,847 |
| 2018 | 2 | — | 0 | 5,983 |
| 2019 | 0 | — | 0 | 15,085 |
| 2020 | 0 | — | 0 | 16,135 |
| 2021 | 0 | — | 0 | 3,725 |
| 2022 | 0 | — | 0 | 1,640 |
| 2023 | 0 | — | 0 | 3,637 |
| 2024 | 0 | — | 0 | 848 |
| 2025 | 0 | — | 0 | 749 |
| 2026 | 0 | — | 0 | — |
Planning a device in HHS? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 884.5380.