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Sutumed SDAG001MR480

by Unilene Sac

Sutumed SDAG001MR480 is a Class II device made by Unilene Sac, cleared under FDA 510(k) K100780 on 14 Dec 2010 and listed in FDA GUDID since 7 Jan 2023 (UDI-DI 07757093000839), 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

510(k) K100780

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07757093000839 UDI-DI Date7 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100780 Date14 Dec 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100780 decided 14 Dec 2010 Active
  • FDA GUDID UDI-DI 07757093000839 listed 7 Jan 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100780
  2. Listed FDA GUDID 07757093000839

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sutumed
Generic name
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Model / reference
SDAG001MR480
Primary DI / UDI-DI
07757093000839
510(k) Number
FDA product code
GAN
GMDN term
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Device class
Class II
Regulation number
878.4830
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Cleared under the same submission (K100780)

and 8 more cleared under K100780

Similar devices in this category

Other devices filed under Polyester suture, bioabsorbable, monofilament, non-antimicrobial.

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)