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rainbow shine SH9814A1

by Genoss

rainbow shine SH9814A1 is a Class II device made by Genoss, cleared under FDA 510(k) K160079 on 10 Nov 2016 and listed in FDA GUDID since 20 Dec 2017 (UDI-DI 08809552960075), 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) K160079

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 Number08809552960075 UDI-DI Date20 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160079 Date10 Nov 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160079 decided 10 Nov 2016 Active
  • FDA GUDID UDI-DI 08809552960075 listed 20 Dec 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160079
  2. Listed FDA GUDID 08809552960075

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
rainbow shine
Generic name
Skin staple remover, reusable
Model / Ref / Catalog
SH9814A1
Primary DI / UDI-DI
08809552960075
510(k) Number
FDA product code
EIH
GMDN term
Skin staple remover, reusable
Device class
Class II
Regulation number
872.6660
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 98 Millimeter

Related devices

Category: Skin staple remover, reusable

Cleared under the same submission (K160079)

and 8 more cleared under K160079

Similar devices

Other devices filed under FDA product code EIH (POWDER, PORCELAIN).

Other devices from Genoss

See all devices from Genoss →

Properties

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