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EEA OrVil EEAORVIL21A

by Covidien LP

EEA OrVil EEAORVIL21A is a Class II device made by Covidien LP, cleared under FDA 510(k) K093402 on 12 Nov 2009 and listed in FDA GUDID since 22 Oct 2015 (UDI-DI 10884521042858), 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) K093402

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 Number10884521042858 UDI-DI Date22 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK093402 Date12 Nov 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K093402 decided 12 Nov 2009 Active
  • FDA GUDID UDI-DI 10884521042858 listed 22 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K093402
  2. Listed FDA GUDID 10884521042858

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EEA OrVil
Generic name
Intraluminal circular stapler, single-use
Model / reference
EEAORVIL21A
Primary DI / UDI-DI
10884521042858
510(k) Number
FDA product code
GDW
GMDN term
Intraluminal circular stapler, single-use
Device class
Class II
Regulation number
878.4750
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 21 Millimeter
Length — 90 Centimeter

Similar devices in this category

Other devices filed under Intraluminal circular stapler, single-use.

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II
  • Shiley 110860

    Class II
  • Shiley 110865

    Class II
  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

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