Skip to content

Relieva Spin RS0616FZ

by Acclarent, Inc.

Relieva Spin RS0616FZ is a Class I device made by Acclarent, Inc., cleared under FDA 510(k) K111875 on 11 Oct 2011 and listed in FDA GUDID since 1 Oct 2016 (UDI-DI 20705031200545), 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) K111875

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 Number20705031200545 UDI-DI Date1 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK111875 Date11 Oct 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111875 decided 11 Oct 2011 Active
  • FDA GUDID UDI-DI 20705031200545 listed 1 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K111875
  2. Listed FDA GUDID 20705031200545

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Relieva Spin
Generic name
Nasal haemostatic balloon
Model / Ref / Catalog
RS0616FZ
Primary DI / UDI-DI
20705031200545
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 (K111875)

and 8 more cleared under K111875

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)