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CeroFrict SML001-PT

by SML Med-Tech Solutions Limited 2 variants

CeroFrict SML001-PT is a Class II device made by SML Med-Tech Solutions Limited, cleared under FDA 510(k) K220884 on 17 Jan 2023 and listed in FDA GUDID since 17 Apr 2023 (UDI-DI 04897129990420), 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) K220884

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 Number04897129990420 UDI-DI Date17 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220884 Date17 Jan 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220884 decided 17 Jan 2023 Active
  • FDA GUDID UDI-DI 04897129990420 listed 17 Apr 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220884
  2. Listed FDA GUDID 04897129990420

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CeroFrict
Generic name
Endoscope air/water valve, single-use
Model / reference
SML001-PT
Primary DI / UDI-DI
04897129990420
510(k) Number
FDA product code
ODC
GMDN term
Endoscope air/water valve, single-use
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscope channel support kitEndoscope suction valve, single-useEndoscope air/water valve, single-useLuminal device flushing tubing set, single-use

Cleared under the same submission (K220884)

and 8 more cleared under K220884

Similar devices

Other devices filed under FDA product code ODC (Endoscope Channel Accessory).

Other devices from SML Med-Tech Solutions Limited

See all devices from SML Med-Tech Solutions Limited →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)