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PTC Spinal Needle 2PTC18

by Hakko Co., Ltd.

PTC Spinal Needle 2PTC18 is a Class II device made by Hakko Co., Ltd., cleared under FDA 510(k) K961151 on 19 Mar 1997 and listed in FDA GUDID since 20 May 2017 (UDI-DI 04526737120416), 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) K961151

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 Number04526737120416 UDI-DI Date20 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK961151 Date19 Mar 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K961151 decided 19 Mar 1997 Active
  • FDA GUDID UDI-DI 04526737120416 listed 20 May 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K961151
  2. Listed FDA GUDID 04526737120416

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PTC Spinal Needle
Generic name
Peripheral nerve-block sharp needle
Model / reference
2PTC18
Description
18G x 2"(51mm) Plastic hub, depth guide Rough surface, calibrations
Primary DI / UDI-DI
04526737120416
510(k) Number
FDA product code
BSP
GMDN term
Peripheral nerve-block sharp needle
Device class
Class II
Regulation number
868.5150
GUDID distribution status
In Commercial Distribution
Size
Length — 51 Millimeter
Needle Gauge — 18 Gauge

Related devices

Category: Peripheral nerve-block sharp needle

Cleared under the same submission (K961151)

and 8 more cleared under K961151

Similar devices

Other devices filed under FDA product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)).

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)