CQ'ENCE Circular Stapler 34mm CS34

by Secqure Surgical, Corp.

CQ'ENCE Circular Stapler 34mm CS34 is a Class II device made by Secqure Surgical, Corp., cleared under FDA 510(k) K120179 on 23 May 2012 and listed in FDA GUDID since 25 Oct 2017 (UDI-DI B092CS340), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB092CS340 UDI-DI	Date25 Oct 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK120179	Date23 May 2012Issued	StatusActive

Official records

FDA 510(k) database 510(k) number K120179

Across registries

2 registries list this device

FDA 510(k) K120179 decided 23 May 2012 Active
FDA GUDID UDI-DI B092CS340 listed 25 Oct 2017 Listed

Timeline

2 dated events

23 May 2012 Cleared FDA 510(k) K120179
25 Oct 2017 Listed FDA GUDID B092CS340

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: CQ'ENCE Circular Stapler 34mm
Generic name: Surgical staple loading unit, non-cutting
Model / Ref / Catalog: CS34

Primary DI / UDI-DI: B092CS340
510(k) Number: K120179
FDA product code: GDW
GMDN term: Surgical staple loading unit, non-cutting

Device class: Class II
Regulation number: 878.4750
GUDID distribution status: In Commercial Distribution

MRI safety: MR Conditional

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Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date

Other properties (9, all answered No)