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Compass Steerable Needle

by Serpex Medical, Inc.

510(k) K221206

Compass Steerable Needle is a medical device (FDA Class II; FDA product code KTI, Bronchoscope Accessory) made by Serpex Medical, Inc., cleared under FDA 510(k) K221206 on 25 Aug 2022, 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 NumberK221206 Date25 Aug 2022ClearedStatusActive

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  • Withdrawn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
KTI
Device class
Class II
Regulation
21 CFR Part 874.4680
Advisory committee
Ear, Nose, Throat
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

Cited by

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

Devices cleared under K221206

1 device · 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 K221206
UDI-DISize and differences
Compass Steerable Needle CSN1001
SERPEX MEDICAL, INC.
CSN100100860009430228
Needle Gauge 22 G
On the market

Similar devices

Other devices filed under FDA product code KTI (Bronchoscope Accessory).

Other devices from Serpex Medical, Inc.

See all devices from Serpex Medical, Inc. →