510(k) Report

FDA applicant

Crossbay Medical, Inc.

San Diego, CA6 decisions2014–20200 recalls

FDA records 6 decisions for Crossbay Medical, Inc. (San Diego, CA) from 2014 to 2020: 6 510(k) clearances. Most are in product codes HHK (Curette, Suction, Endometrial (And Accessories)) and MQF (Catheter, Assisted Reproduction). Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Crossbay Medical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Crossbay Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2014: 12015: 12017: 12019: 12020: 2
2014high 2 (2020) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Crossbay Medical, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Crossbay Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report