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RapidVac SEA3730

by Covidien LP

Ref SEA3730

RapidVac SEA3730 is a device classified as Class I in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 0763000B00003377L), cleared under FDA 510(k) K980915 on 29 Jun 1998 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884524001449), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K980915

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00003377L Basic UDI-DI 10884524001449UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884524001449 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK980915 Date29 Jun 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00003377L registered 28 May 2026 Active
  • FDA 510(k) K980915 decided 29 Jun 1998 Active
  • FDA GUDID UDI-DI 10884524001449 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K980915
  2. Listed FDA GUDID 10884524001449
  3. Registered EUDAMED 0763000B00003377L

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
RapidVacTM EUDAMED
RapidVac GUDID
Generic name
Electrical-only medical device connection cable, reusable
Device name
SEA3725 RapidVac Smoke Tubing, 7/8" x 8"
Model / reference
SEA3730
Primary DI / UDI-DI
10884524001449
Basic UDI-DI
0763000B00003377L
510(k) Number
FDA product code
FYD
EMDN code
Z12019004 Surgical smoke evacuation systems
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.5070
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K980915)

and 6 more cleared under K980915

Similar devices in this category

Other devices filed under SURGICAL SMOKE EVACUATION SYSTEMS.

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

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)