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Jelco 402315

by ICU Medical, Inc.

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) K071785

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00351688070886 UDI-DI Date12 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK071785 Date2 Aug 2007DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Jelco
Generic name
Hypodermic needle, single-use
Model / reference
402315
Primary DI / UDI-DI
00351688070886
510(k) Number
FDA product code
FMI
GMDN term
Hypodermic needle, single-use
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hypodermic needle, single-use

Cleared under the same submission (K071785)

Show all (12)

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (9)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No