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Relieva Luma Sentry SIS100B

by Acclarent, Inc.

Relieva Luma Sentry SIS100B is a Class I device made by Acclarent, Inc., cleared under FDA 510(k) K071845 on 28 Sep 2007 and listed in FDA GUDID since 1 Oct 2016 (UDI-DI 10705031135635), 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) K071845

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 Number10705031135635 UDI-DI Date1 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK071845 Date28 Sep 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K071845 decided 28 Sep 2007 Active
  • FDA GUDID UDI-DI 10705031135635 listed 1 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K071845
  2. Listed FDA GUDID 10705031135635

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Relieva Luma Sentry
Generic name
Paranasal sinus-illumination light guide cable
Model / Ref / Catalog
SIS100B
Primary DI / UDI-DI
10705031135635
510(k) Number
FDA product code
KAM
GMDN term
Paranasal sinus-illumination light guide cable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Paranasal sinus-illumination light guide cable

Cleared under the same submission (K071845)

Similar devices

Other devices filed under FDA product code KAM (CANNULA, SINUS).

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)