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Dukal 5156

by Dukal LLC

Dukal 5156 is a Class I device made by Dukal LLC, cleared under FDA 510(k) K931005 on 14 Jul 1993 and listed in FDA GUDID since 6 Dec 2022 (UDI-DI 10665973008827), 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) K931005

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 Number10665973008827 UDI-DI Date6 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK931005 Date14 Jul 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K931005 decided 14 Jul 1993 Active
  • FDA GUDID UDI-DI 10665973008827 listed 6 Dec 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K931005
  2. Listed FDA GUDID 10665973008827

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dukal
Generic name
Skin-closure adhesive strip
Model / Ref / Catalog
5156
Primary DI / UDI-DI
10665973008827
510(k) Number
FDA product code
FPX
GMDN term
Skin-closure adhesive strip
Device class
Class I
Regulation number
880.5240
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FPX (Strip, adhesive, closure, skin).

Other devices from Dukal LLC

See all devices from Dukal LLC →

Properties

  • Supplied sterile
  • Single use
  • Over-the-counter
  • Lot / batch number
Other properties (11, all answered No)