510(k) · Cleared

Cleared

Cypris eXact Suture Placement Device

K240185510(k) TraditionalCleared May 3, 2024101-day reviewClass I21 CFR 878.4800

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

Cypris Medical · GEJ Carrier, Ligature

Cleared on May 3, 2024 after a 101-day review. The FDA summary names its predicate without a number.

Decided: May 3, 2024
Review: 101 days
Class: Class I
Product code: GEJ
Recalls: None
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K240185Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	Cypris eXact 5.1 Suture Placement Device Named without a submission number			—
†	K233355	Cypris eXact Suturing System	Cypris Medical	2024	—
†	K994290	Bard Endoscopic Suturing System	C.R. Bard, Inc.	2000	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GEJ devices

GEJ Carrier, Ligature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · GEJ

1in 2024

2007high 1 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEJ

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

Recalls per year · GEJ

No recall names GEJ since 2007.

Adverse event reports per year · GEJ

1in 2024

2007high 2 (2017) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	1
2017	0	—	2
2018	0	—	2
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	1	—	1
2025	0	—	0
2026	0	—	—

What is it indicated for?

The Cypris eXact Suture Placement Device is indicated for use in general soft tissue approximation when used with sutures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K240185 · printed Nov 4, 2026

Cite this page

510(k) Report. “K240185: Cypris eXact Suture Placement Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240185

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026