Skip to content

Compass Steerable Needle CSN1001

by Serpex Medical, Inc. 2 variants

Compass Steerable Needle CSN1001 is a flexible endoscopic biopsy handpiece/needle (FDA Class II; FDA product code KTI, Bronchoscope Accessory) made by Serpex Medical, Inc., cleared under FDA 510(k) K221206 on 25 Aug 2022 and listed in FDA GUDID since 17 Mar 2023 (UDI-DI 00860009430228), 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) K221206

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 Number00860009430228 UDI-DI Date17 Mar 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK221206 Date25 Aug 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221206 decided 25 Aug 2022 Active
  • FDA GUDID UDI-DI 00860009430228 listed 17 Mar 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K221206
  2. Listed FDA GUDID 00860009430228

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  • Withdrawn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
Flexible endoscopic biopsy handpiece/needle
Model / reference
CSN1001
Primary DI / UDI-DI
00860009430228
510(k) Number
FDA product code
KTI
GMDN term
Flexible endoscopic biopsy handpiece/needle
Device class
Class II
Regulation number
874.4680
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 22 Gauge

Related devices

Category: Flexible endoscopic biopsy handpiece/needle

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)