SuturTek 360 Degree Sternal Closure Device

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K082828 ↗

FDA Product Code

GAQ

Device Class

Class II

Regulation

21 CFR Part 878.4495

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Suturtek Fastclose Sternum Closure Device

  Class II

  FDA 510(k) K032468 Active Cleared 23 Sep 2003

• Suturtek Fastclose Suturing Device

  Class II

  FDA 510(k) K030227 Active Cleared 17 Mar 2003

• Suturtek Surgical Steel Suture, Models Sc-S13, Sc-S14, Sc-S15, Sc-S16, Sc-S17

  Class II

  FDA 510(k) K063603 Active Cleared 7 Feb 2007

• What is the SuturTek 360 Degree Sternal Closure Device specifically designed to assist with during surgery?

  The SuturTek 360 Degree Sternal Closure Device is designed to facilitate the passage of stainless steel needles through the sternum, helping to secure sutures for proper sternal closure after a sternotomy procedure. It uses a cartridge-loaded needle and suture system with an internal drive mechanism to automate needle engagement and insertion.

• Is the SuturTek 360 Degree Sternal Closure Device intended for reuse or is it single-use only?

  The device is explicitly supplied as a sterile, single-use instrument, meaning it is intended for one-time use only in a surgical setting. Reuse is not recommended or supported by the manufacturer.

• How should the SuturTek 360 Degree Sternal Closure Device be stored to maintain sterility?

  Since it is a sterile surgical instrument, storage must follow standard sterile instrument protocols. The device should be kept in its original packaging until ready for use, protected from contamination, moisture, and physical damage. Avoid exposure to extreme temperatures or direct sunlight.

• What regulatory pathway does the SuturTek 360 Degree Sternal Closure Device follow, and where is it manufactured?

  The device holds FDA 510(k) clearance (K082828) and is classified under 21 CFR 878.4495, adhering to Class II medical device standards. It is manufactured by Suturtek Incorporated, located at 6 Brookside Cir., Acton, MA 01720.

• Does the SuturTek 360 Degree Sternal Closure Device come in multiple sizes or models?

  The provided data does not specify distinct sizes or models beyond the core design (a cartridge-loaded needle and suture system). However, the OpenFDA registration lists multiple FEI numbers, which may correspond to variations in packaging, lot sizes, or distribution channels rather than physical device modifications. For exact sizing or model variations, consult the manufacturer’s technical documentation or catalog.