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ENT Em

by Brainlab AG

510(k) K223734

ENT Em is a Class II device made by Brainlab AG, cleared under FDA 510(k) K223734 on 27 Apr 2023, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK223734 Date27 Apr 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PGW
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K223734

19 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K223734
UDI-DISize and differences
Curve Navigation 17700
Brainlab SE
1770004056481142520
Prescription: yes; Single use: no
No longer on the market
Curve Navigation 17700 17701
Brainlab SE
1770104056481144500
Prescription: yes; Single use: no
On the market
Curve Navigation 17702
Brainlab SE
1770204056481146702
Prescription: yes; Single use: no
On the market
Disposable Skull Reference Bone Fixation Screw 1.5 mm x 6 mm 52172
Brainlab SE
5217204056481144685
Prescription: yes; Single use: yes
On the market
Disposable Skull Reference Drill Bit 1.1 mm for Bone Fixation Screw 52173
Brainlab SE
5217304056481144692
Prescription: yes; Single use: yes
On the market
EM Instrument Tracker 18099-05A
Brainlab SE
18099-05A / 18099-05A04056481004873
Prescription: yes; Single use: no
On the market
EM Patient Reference 18099-24
Brainlab SE
18099-24 / 18099-2404056481004804
Prescription: yes; Single use: no
On the market
EM Pointer 18099-02C
Brainlab SE
18099-02C / 18099-02C04056481004927
Prescription: no; Single use: no
On the market
EM Registration Pointer 18099-23
Brainlab SE
18099-23 / 18099-2304056481004811
Prescription: yes; Single use: no
On the market
EM Short Pointer 18099-27
Brainlab SE
18099-27 / 18099-2704056481140410
Prescription: yes; Single use: no
On the market
Kick 2 Navigation Station EM 18202
Brainlab SE
1820204056481143725
Prescription: yes; Single use: no
On the market
Navigation SW ENT EM 1.2
Brainlab SE
22241-06B / 1.204056481138813
Prescription: no; Single use: no
On the market
Skull Reference Base EM 18099-06
Brainlab SE
18099-06 / 18099-0604056481004866
Prescription: yes; Single use: no
On the market
Starlink Suction Tube Frazier-Tip 45° Angled 10 FR 55790-70
Brainlab SE
55790-70 / 55790-7004056481001421
Prescription: yes; Single use: no
On the market
Starlink Suction Tube Frazier-Tip 45° Angled 8 FR 55790-75
Brainlab SE
55790-75 / 55790-7504056481001414
Prescription: yes; Single use: no
On the market
Starlink Suction Tube Frazier-Tip 70° Angled 10 FR 55790-65
Brainlab SE
55790-65 / 55790-6504056481001438
Prescription: yes; Single use: no
On the market
Starlink Suction Tube Frazier-Tip 70° Angled 8 FR 55790-55
Brainlab SE
55790-55 / 55790-5504056481001452
Prescription: yes; Single use: no
On the market
Starlink Suction Tube Olive-Tip 45° Angled 8 FR 55790-05A
Brainlab SE
55790-05A / 55790-05A04056481001551
Prescription: yes; Single use: no
On the market
Starlink Suction Tube Olive-Tip 70° Angled 8 FR 55790-50A
Brainlab SE
55790-50A / 55790-50A04056481001469
Prescription: yes; Single use: no
On the market

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