truFreeze
Model 2000177 · US Endoscopy · DI 00724995199227
GEH — Unit, Cryosurgical, Accessories · Class II · 21 CFR 878.4350
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (15)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Malfunction: 13 · Injury: 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4 |
| 2019-02 | 0 | 1.25 |
| 2019-03 | 0 | 1.8 |
| 2019-04 | 0 | 2 |
| 2019-05 | 0 | 1.75 |
| 2019-06 | 0 | 1.5 |
| 2019-07 | 2 | 2.24 |
| 2019-08 | 0 | 1.89 |
| 2019-09 | 0 | 2.38 |
| 2019-10 | 0 | 2.46 |
| 2019-11 | 0 | 4.11 |
| 2019-12 | 0 | 3 |
| 2020-01 | 0 | 3 |
| 2020-02 | 0 | 5 |
| 2020-03 | 0 | 2.85 |
| 2020-04 | 0 | 4.25 |
| 2020-05 | 0 | 2.5 |
| 2020-06 | 0 | 2.75 |
| 2020-07 | 0 | 2.38 |
| 2020-08 | 0 | 2.82 |
| 2020-09 | 0 | 3.14 |
| 2020-10 | 0 | 1.25 |
| 2020-11 | 0 | 5 |
| 2020-12 | 0 | 1.22 |
| 2021-01 | 0 | 1.8 |
| 2021-02 | 0 | 5 |
| 2021-03 | 0 | 2.38 |
| 2021-04 | 0 | 1.9 |
| 2021-05 | 0 | 2.13 |
| 2021-06 | 0 | 2.25 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 2.8 |
| 2021-09 | 0 | 1.86 |
| 2021-10 | 0 | 1.33 |
| 2021-11 | 0 | 3.33 |
| 2021-12 | 0 | 2.67 |
| 2022-01 | 0 | 2.36 |
| 2022-02 | 0 | 1.25 |
| 2022-03 | 0 | 2 |
| 2022-04 | 0 | 1.77 |
| 2022-05 | 0 | 1.75 |
| 2022-06 | 0 | 2 |
| 2022-07 | 0 | 2.1 |
| 2022-08 | 0 | 3.57 |
| 2022-09 | 0 | 2.11 |
| 2022-10 | 0 | 2.1 |
| 2022-11 | 0 | 2.4 |
| 2022-12 | 0 | 1.43 |
| 2023-01 | 0 | 2.14 |
| 2023-02 | 0 | 1.3 |
| 2023-03 | 1 | 2.38 |
| 2023-04 | 0 | 1.7 |
| 2023-05 | 1 | 1.25 |
| 2023-06 | 1 | 1.29 |
| 2023-07 | 1 | 1.57 |
| 2023-08 | 0 | 3.2 |
| 2023-09 | 0 | 1.71 |
| 2023-10 | 0 | 1.45 |
| 2023-11 | 0 | 3 |
| 2023-12 | 0 | 1 |
| 2024-01 | 0 | 1.25 |
| 2024-02 | 0 | 1.44 |
| 2024-03 | 0 | 1.43 |
| 2024-04 | 0 | 1 |
| 2024-05 | 0 | 1 |
| 2024-06 | 3 | 1.4 |
| 2024-07 | 0 | 1.4 |
| 2024-08 | 3 | 1.33 |
| 2024-09 | 0 | 1.67 |
| 2024-10 | 0 | 2.17 |
| 2024-11 | 0 | 2 |
| 2024-12 | 2 | 2.5 |
| 2025-01 | 0 | 1.43 |
| 2025-02 | 0 | 1.33 |
| 2025-03 | 0 | 1.3 |
| 2025-04 | 0 | 1.86 |
| 2025-05 | 0 | 1.64 |
| 2025-07 | 0 | 2 |
| 2025-08 | 0 | 1.67 |
| 2025-09 | 0 | 2.2 |
| 2025-10 | 0 | 1.33 |
| 2025-11 | 0 | 1.89 |
| 2025-12 | 0 | 3.17 |
| 2026-01 | 0 | 3 |
| 2026-02 | 1 | 3 |
| 2026-03 | 0 | 2.08 |
| 2026-04 | 0 | 2.57 |
| 2026-05 | 0 | 3.17 |
| 2026-06 | 0 | 2.71 |
Regulatory clearances
- K223369 SESE 2022-12-02 (k number procode)
- K222272 SESE 2022-08-18 (k number procode)
- K171626 SESE 2017-08-30 (k number procode)
Predicate lineage
K171626 — cites (transitively): K083737 (d1), K133258 (d1), K152329 (d1), K163244 (d1), K131523 (d2), K143625 (d2), K151054 (d2), K162695 (d2), K101825 (d3), K161557 (d3), K021387 (d4), K060555 (d4), K070893 (d4), K150920 (d4), K160273 (d4), K152668 (d5) — cited as predicate by K201056, K201183, K222272
K222272 — cites (transitively): K171626 (d1), K083737 (d2), K133258 (d2), K152329 (d2), K163244 (d2), K131523 (d3), K143625 (d3), K151054 (d3), K162695 (d3), K101825 (d4), K161557 (d4), K021387 (d5), K060555 (d5), K070893 (d5), K150920 (d5), K160273 (d5), K152668 (d6) — cited as predicate by K223369
K223369 — cites (transitively): K222272 (d1), K171626 (d2), K083737 (d3), K133258 (d3), K152329 (d3), K163244 (d3), K131523 (d4), K143625 (d4), K151054 (d4), K162695 (d4), K101825 (d5), K161557 (d5), K021387 (d6), K060555 (d6), K070893 (d6), K150920 (d6), K160273 (d6), K152668 (d7)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — US Endoscopy
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