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SkyOPS S0021

by Sky Surgical

SkyOPS S0021 is a Class II device made by Sky Surgical, cleared under FDA 510(k) K233154 on 21 Dec 2023 and listed in FDA GUDID since 7 May 2026 (UDI-DI 00850024702561), active as of 22 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 22 Oct 2026

Documents

510(k) K233154

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850024702561 UDI-DI Date7 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233154 Date21 Dec 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233154 decided 21 Dec 2023 Active
  • FDA GUDID UDI-DI 00850024702561 listed 7 May 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K233154
  2. Listed FDA GUDID 00850024702561

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SkyOPS
Generic name
Instrument tray, reusable
Model / reference
S0021
Primary DI / UDI-DI
00850024702561
510(k) Number
FDA product code
KCT
GMDN term
Instrument tray, reusable
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K233154)

and 8 more cleared under K233154

Similar devices

Other devices filed under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).

Other devices from Sky Surgical

  • SkyOPS S0006

    Class II

  • SkyOPS S0009

    Class II

  • SkyOPS S0015

    Class II

  • SkyOPS S0022

    Class II

See all devices from Sky Surgical →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)