Sutumed SDNN001MC360

Sutumed SDNN001MC360 is a Class II device made by Unilene Sac, cleared under FDA 510(k) K123034 on 28 May 2013 and listed in FDA GUDID since 6 Jan 2023 (UDI-DI 07757093013587), 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	Number07757093013587 UDI-DI	Date6 Jan 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK123034	Date28 May 2013Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07757093013587
FDA 510(k) database 510(k) number K123034

Across registries

2 registries list this device

FDA 510(k) K123034 decided 28 May 2013 Active
FDA GUDID UDI-DI 07757093013587 listed 6 Jan 2023 Listed

Timeline

2 dated events

28 May 2013 Cleared FDA 510(k) K123034
6 Jan 2023 Listed FDA GUDID 07757093013587

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Sutumed
Generic name: Nylon suture, non-bioabsorbable, monofilament
Model / Ref / Catalog: SDNN001MC360

Primary DI / UDI-DI: 07757093013587
510(k) Number: K123034
FDA product code: GAR
GMDN term: Nylon suture, non-bioabsorbable, monofilament

Device class: Class II
Regulation number: 878.5020
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Nylon suture, non-bioabsorbable, monofilament.

Other devices from Unilene Sac

See all devices from Unilene Sac →

Properties

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

Other properties (8, all answered No)