The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- European UnionMontgomery Salivary Bypass TubeB-14063107100311
Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
No recalls linked.
Predicate lineage
Cited as predicate by: K130736
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2013-03-20 | NAI | No action indicated | Boston Medical Products, Inc. | 0 |
| 2013-03-20 | NAI | No action indicated | Boston Medical Products, Inc. | 0 |
- AESCULAP Aesculap AG
- AESCULAP AESCULAP, INC.
- AESCULAP Aesculap AG
- AESCULAP Aesculap AG
- AESCULAP Aesculap AG
- DILATOR CERVICAL SET OF 6 BIOPSY FINE CUT INSTRUMENTS
- HANK DILATOR DOUBLE ENDED 7/8 FR BIOPSY FINE CUT INSTRUMENTS
- HANK DILATOR SET OF 6 (Z304) BIOPSY FINE CUT INSTRUMENTS
- Hercules COOK INCORPORATED
- Hercules COOK INCORPORATED
- Hercules COOK INCORPORATED
- Hercules COOK INCORPORATED