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DemeCRYL G1084045A4P

by DemeTECH Corp

DemeCRYL G1084045A4P is a Class II device made by DemeTECH Corp, cleared under FDA 510(k) K043539 on 6 Apr 2005 and listed in FDA GUDID since 24 Jun 2019 (UDI-DI 10652927302551), 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) K043539

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 Number10652927302551 UDI-DI Date24 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK043539 Date6 Apr 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K043539 decided 6 Apr 2005 Active
  • FDA GUDID UDI-DI 10652927302551 listed 24 Jun 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K043539
  2. Listed FDA GUDID 10652927302551

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DemeCRYL
Generic name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Model / reference
G1084045A4P
Description
Synthetic (polyglactin 910) , Absorbable Suture
Primary DI / UDI-DI
10652927302551
510(k) Number
FDA product code
GAM
GMDN term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Device class
Class II
Regulation number
878.4493
GUDID distribution status
In Commercial Distribution

Related devices

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

Cleared under the same submission (K043539)

and 8 more cleared under K043539

Similar devices in this category

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

Other devices from DemeTECH Corp

See all devices from DemeTECH Corp →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)