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Sonopsy-C1 SON21100

by Hakko Co., Ltd.

Sonopsy-C1 SON21100 is a Class II device made by Hakko Co., Ltd., cleared under FDA 510(k) K013109 on 12 Mar 2002 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04526737120058), 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) K013109

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 Number04526737120058 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK013109 Date12 Mar 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K013109 decided 12 Mar 2002 Active
  • FDA GUDID UDI-DI 04526737120058 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K013109
  2. Listed FDA GUDID 04526737120058

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sonopsy-C1
Generic name
Soft-tissue biopsy needle, single-use
Model / reference
SON21100
Description
1 21G x 100mm biopsy needle with suction syringe 3 Filter paper
Primary DI / UDI-DI
04526737120058
510(k) Number
FDA product code
FCG
GMDN term
Soft-tissue biopsy needle, single-use
Device class
Class II
Regulation number
876.1075
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 21 Gauge
Length — 100 Millimeter

Related devices

Category: Soft-tissue biopsy needle, single-use

Cleared under the same submission (K013109)

Similar devices

Other devices filed under FDA product code FCG (Biopsy Needle Kit).

Other devices from Hakko Co., Ltd.

See all devices from Hakko Co., Ltd. →

Properties

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