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InstaClear LCS4K70BTOL

by Gyrus Acmi, Inc.

Ref LCS4K70BTOL

InstaClear LCS4K70BTOL is a device classified as Class IIa in the EU and Class II in the US made by Gyrus Acmi, Inc., registered in EUDAMED on 10 Oct 2026 (Basic UDI-DI B-00821925041455), cleared under FDA 510(k) K152531 on 15 Jan 2016 and listed in FDA GUDID since 22 Apr 2024 (UDI-DI 00821925041455), active as of 24 Oct 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152531

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00821925041455 Basic UDI-DI 00821925041455UDI-DIDate10 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925041455 UDI-DI Date22 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK152531 Date15 Jan 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00821925041455 registered 10 Oct 2026 Active
  • FDA 510(k) K152531 decided 15 Jan 2016 Active
  • FDA GUDID UDI-DI 00821925041455 listed 22 Apr 2024 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1888-2024 FDA Class II initiated 3 Apr 2024

    Potential for distal end of the sheath to break off during a procedure.

    • Ongoing Z-1368-2024 FDA Class II initiated 16 Jan 2024

    Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be updated to reflect the instructions in the English IFU

Timeline

5 dated events

  1. Cleared FDA 510(k) K152531
  2. Recall initiated FDA recalls Z-1368-2024
  3. Recall initiated FDA recalls Z-1888-2024
  4. Listed FDA GUDID 00821925041455
  5. Registered EUDAMED B-00821925041455

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
InstaClear
Generic name
Flexible fibreoptic nasopharyngoscope
Device name
LCS4K70BTOL
Model / reference
LCS4K70BTOL
Primary DI / UDI-DI
00821925041455 EUDAMED
00821925041523 GUDID
Basic UDI-DI
B-00821925041455
510(k) Number
FDA product code
EOB
EMDN code
Z12029015 Lens cleaning units
GMDN term
Flexible fibreoptic nasopharyngoscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.4760
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00821925041455
GUDID
00821925041523
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00821925041455; FDA GUDID lists 00821925041523), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Flexible fibreoptic nasopharyngoscope

Cleared under the same submission (K152531)

and 8 more cleared under K152531

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)