Skip to content

Surgyco SSN03005

by Surgyco LLC

Surgyco SSN03005 is a Class II device made by Surgyco LLC, cleared under FDA 510(k) K170651 on 2 Aug 2017 and listed in FDA GUDID since 29 Sep 2022 (UDI-DI 10850044799456), 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) K170651

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 Number10850044799456 UDI-DI Date29 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170651 Date2 Aug 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170651 decided 2 Aug 2017 Active
  • FDA GUDID UDI-DI 10850044799456 listed 29 Sep 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170651
  2. Listed FDA GUDID 10850044799456

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Surgyco
Generic name
General-purpose syringe, single-use
Model / reference
SSN03005
Primary DI / UDI-DI
10850044799456
510(k) Number
FDA product code
FMI, FMF, MEG
GMDN term
General-purpose syringe, single-use
Device class
Class II
Regulation number
880.5570, 880.5860
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under General-purpose syringe, single-use.

Other devices from Surgyco LLC

See all devices from Surgyco LLC →

Properties

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