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Surgyco 010-VPSB21G2

by Surgyco LLC

Surgyco 010-VPSB21G2 is a Class II device made by Surgyco LLC, cleared under FDA 510(k) K230080 on 7 Jul 2023 and listed in FDA GUDID since 23 Dec 2025 (UDI-DI 10850074089060), 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) K230080

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 Number10850074089060 UDI-DI Date23 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK230080 Date7 Jul 2023IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K230080 decided 7 Jul 2023 Active
  • FDA GUDID UDI-DI 10850074089060 listed 23 Dec 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K230080
  2. Listed FDA GUDID 10850074089060

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  • Withdrawn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
010-VPSB21G2
Primary DI / UDI-DI
10850074089060
510(k) Number
FDA product code
JKA
GMDN term
General-purpose syringe, single-use
Device class
Class II
Regulation number
862.1675
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K230080)

and 1 more cleared under K230080

Similar devices

Other devices filed under FDA product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection).

Other devices from Surgyco LLC

See all devices from Surgyco LLC →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)