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Surgipro SMPM-02

by Covidien LP

Surgipro SMPM-02 is a Class II device made by Covidien LP, cleared under FDA 510(k) K982575 on 6 Nov 1998 and listed in FDA GUDID since 2 Sep 2015 (UDI-DI 10884521101302), 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) K982575

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 Number10884521101302 UDI-DI Date2 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK982575 Date6 Nov 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K982575 decided 6 Nov 1998 Active
  • FDA GUDID UDI-DI 10884521101302 listed 2 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K982575
  2. Listed FDA GUDID 10884521101302

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Surgipro
Generic name
Extra-gynaecological surgical mesh, composite-polymer
Model / reference
SMPM-02
Primary DI / UDI-DI
10884521101302
510(k) Number
FDA product code
FTL
GMDN term
Extra-gynaecological surgical mesh, composite-polymer
Device class
Class II
Regulation number
878.3300
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Extra-gynaecological surgical mesh, composite-polymer.

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)