Print-ready dossier — use your browser's print dialog to save as PDF.
SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO
Model C010012 · OBP CORPORATION · DI M648C0100120
HET — Laparoscope, Gynecologic (And Accessories) · Class II · 21 CFR 884.1720
HIH — Hysteroscope (And Accessories) · Class II · 21 CFR 884.1690
ODC — Endoscope Channel Accessory · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-15 · 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 (0)
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
3.7
2019-02
0
2.41
2019-03
0
3.28
2019-04
0
3.17
2019-05
0
2
2019-06
0
3.61
2019-07
0
3.83
2019-08
0
3
2019-09
0
2.1
2019-10
0
3.11
2019-11
0
2.61
2019-12
0
3.86
2020-01
0
2.71
2020-02
0
2.95
2020-03
0
3.61
2020-04
0
3.5
2020-05
0
2.71
2020-06
0
4.26
2020-07
0
3.11
2020-08
0
3.81
2020-09
0
3.61
2020-10
0
5.31
2020-11
0
5.54
2020-12
0
5.43
2021-01
0
4.3
2021-02
0
4.75
2021-03
0
6.18
2021-04
0
7.3
2021-05
0
6.04
2021-06
0
7.26
2021-07
0
6.76
2021-08
0
5.5
2021-09
0
5.69
2021-10
0
6.75
2021-11
0
5.11
2021-12
0
7.64
2022-01
0
8.62
2022-02
0
10.9
2022-03
0
12
2022-04
0
10.68
2022-05
0
11.19
2022-06
0
10.21
2022-07
0
10.76
2022-08
0
10.48
2022-09
0
7.3
2022-10
0
8.05
2022-11
0
10.06
2022-12
0
15.11
2023-01
0
19.3
2023-02
0
11.33
2023-03
0
16.24
2023-04
0
15.12
2023-05
0
16.88
2023-06
0
17.55
2023-07
0
13.48
2023-08
0
14
2023-09
0
13.47
2023-10
0
13.55
2023-11
0
13.85
2023-12
0
13.39
2024-01
0
11.22
2024-02
0
12.13
2024-03
0
13.75
2024-04
0
16.47
2024-05
0
23.68
2024-06
0
22.71
2024-07
0
21.81
2024-08
0
21.14
2024-09
0
23.33
2024-10
0
22.49
2024-11
0
14.48
2024-12
0
21.9
2025-01
0
23.52
2025-02
0
21.12
2025-03
0
17.12
2025-04
0
15.93
2025-05
0
17.63
2025-06
0
15.44
2025-07
0
16.23
2025-08
0
16.57
2025-09
0
13.56
2025-10
0
17.97
2025-11
0
21.32
2025-12
0
29.27
2026-01
0
18.35
2026-02
0
22.08
2026-03
0
21.88
2026-04
0
24.16
2026-05
0
19.84
2026-06
0
17.1
This device (reports/month)Average device in HET, HIH, ODC (reports/device/month)