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Endobutton 7209354

by Smith & Nephew, Inc.

Endobutton 7209354 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 30 Aug 2015 (UDI-DI 03596010469588), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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 Number03596010469588 UDI-DI Date30 Aug 2015ListedStatusListed GUDID: not 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 03596010469588 listed 30 Aug 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K980155
  2. Listed FDA GUDID 03596010469588

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  • Withdrawn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
7209354
Primary DI / UDI-DI
03596010469588
510(k) Number
FDA product code
MBI, GAT
GMDN term
Tendon/ligament bone anchor, non-bioabsorbable
Device class
Class II
Regulation number
888.3040, 878.5000
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K980155)

and 8 more cleared under K980155

Similar devices

Other devices filed under FDA product code MBI (FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE).

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)