510(k) Report

FDA product code · Obstetrics and gynecology

Device, Thermal Ablation, Endometrial

MNBClass IIIPMA required9 decisions since 19979 recalls

9 FDA decisions since 1997. 9 recalls name this code, 0 of them Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, obstetrics and gynecology panel

Twenty years of MNB 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 · MNB

4in 2025

2007: 92008: 142009: 132010: 182011: 182012: 82013: 172014: 202015: 72016: 52017: 82018: 92019: 82020: 192021: 222022: 92023: 162024: 132025: 42026 (partial year): 4
2007high 22 (2021) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNB

Too few MNB 510(k)s in any year since 2007 to give a median.

Recalls per year · MNB

2in 2009

2007: 52009: 2
2007high 5 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNB

250in 2025

2007: 1802008: 2902009: 7922010: 3892011: 4332012: 4082013: 3682014: 3092015: 3182016: 2962017: 2922018: 2622019: 2492020: 1972021: 2292022: 1792023: 2132024: 2132025: 250
2007high 792 (2009) · low 179 (2022)2025

MAUDE reports naming product code MNB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079—5180
200814—0290
200913—2792
201018—0389
201118—0433
20128—0408
201317—0368
201420—0309
20157—0318
20165—0296
20178—0292
20189—0262
20198—0249
202019—0197
202122—0229
20229—0179
202316—0213
202413—0213
20254—0250
20264—0—
FIG. 1 — MNB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MNB? 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) Report