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Compass Steerable Needle CSN1001

by Serpex Medical, Inc. 2 variants

Compass Steerable Needle CSN1001 is a body aspiration needle (FDA Class II; FDA product code KTI, Bronchoscope Accessory) made by Serpex Medical, Inc., cleared under FDA 510(k) K252874 on 8 Oct 2025 and listed in FDA GUDID since 8 Dec 2025 (UDI-DI 00860009430211), 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) K252874

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 Number00860009430211 UDI-DI Date8 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK252874 Date8 Oct 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K252874 decided 8 Oct 2025 Active
  • FDA GUDID UDI-DI 00860009430211 listed 8 Dec 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K252874
  2. Listed FDA GUDID 00860009430211

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Compass Steerable Needle
Generic name
Body aspiration needle, single-use
Model / reference
CSN1001
Primary DI / UDI-DI
00860009430211
510(k) Number
FDA product code
KTI
GMDN term
Body aspiration needle, single-use
Device class
Class II
Regulation number
874.4680
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K252874)

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. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)