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Morrison Steerable Needle 13550

by Apriomed AB

Morrison Steerable Needle 13550 is a Class II device made by Apriomed AB, cleared under FDA 510(k) K150625 on 9 Jun 2015 and listed in FDA GUDID since 5 Sep 2016 (UDI-DI 07350031355505), active as of 23 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 23 Oct 2026

Documents

510(k) K150625

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07350031355505 UDI-DI Date5 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150625 Date9 Jun 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150625 decided 9 Jun 2015 Active
  • FDA GUDID UDI-DI 07350031355505 listed 5 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K150625
  2. Listed FDA GUDID 07350031355505

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Morrison Steerable Needle
Generic name
Body aspiration needle, single-use
Model / Ref / Catalog
13550
Primary DI / UDI-DI
07350031355505
510(k) Number
FDA product code
KNW
GMDN term
Body aspiration needle, single-use
Device class
Class II
Regulation number
876.1075
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Length — 17 Centimeter
Needle Gauge — 21 Gauge

Similar devices in this category

Other devices filed under Body aspiration needle, single-use.

Other devices from Apriomed AB

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)