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Relieva Spinplus RSP0616M

by Acclarent, Inc.

Relieva Spinplus RSP0616M is a Class I device made by Acclarent, Inc., cleared under FDA 510(k) K143541 on 22 Apr 2015 and listed in FDA GUDID since 1 Oct 2016 (UDI-DI 10705031232938), 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) K143541

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 Number10705031232938 UDI-DI Date1 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143541 Date22 Apr 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143541 decided 22 Apr 2015 Active
  • FDA GUDID UDI-DI 10705031232938 listed 1 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K143541
  2. Listed FDA GUDID 10705031232938

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Relieva Spinplus
Generic name
Nasal haemostatic balloon
Model / Ref / Catalog
RSP0616M
Primary DI / UDI-DI
10705031232938
510(k) Number
FDA product code
LRC
GMDN term
Nasal haemostatic balloon
Device class
Class I
Regulation number
874.4420
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nasal haemostatic balloon

Cleared under the same submission (K143541)

and 8 more cleared under K143541

Similar devices in this category

Other devices filed under Nasal haemostatic balloon.

Other devices from Acclarent, Inc.

See all devices from Acclarent, Inc. →

Properties

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