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Endobutton 7207324

by Smith & Nephew, Inc.

Endobutton 7207324 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K980155 on 1 Apr 1998 and listed in FDA GUDID since 29 Aug 2015 (UDI-DI 03596010388285), 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) K980155

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 Number03596010388285 UDI-DI Date29 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK980155 Date1 Apr 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K980155 decided 1 Apr 1998 Active
  • FDA GUDID UDI-DI 03596010388285 listed 29 Aug 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K980155
  2. Listed FDA GUDID 03596010388285

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Endobutton
Generic name
Tendon/ligament bone anchor, non-bioabsorbable
Model / Ref / Catalog
7207324
Primary DI / UDI-DI
03596010388285
510(k) Number
FDA product code
GAT, MBI
GMDN term
Tendon/ligament bone anchor, non-bioabsorbable
Device class
Class II
Regulation number
878.5000, 888.3040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tendon/ligament bone anchor, non-bioabsorbable

Cleared under the same submission (K980155)

and 8 more cleared under K980155

Similar devices in this category

Other devices filed under Tendon/ligament bone anchor, non-bioabsorbable.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

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