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Surgistar 121636

by Surgistar Inc.

Surgistar 121636 is a Class I device made by Surgistar Inc., cleared under FDA 510(k) K961524 on 16 May 1996 and listed in FDA GUDID since 3 Jun 2016 (UDI-DI 00878799006820), 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) K961524

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 Number00878799006820 UDI-DI Date3 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK961524 Date16 May 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K961524 decided 16 May 1996 Active
  • FDA GUDID UDI-DI 00878799006820 listed 3 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K961524
  2. Listed FDA GUDID 00878799006820

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Surgistar
Generic name
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Model / reference
121636
Primary DI / UDI-DI
00878799006820
510(k) Number
FDA product code
HMX
GMDN term
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Device class
Class I
Regulation number
886.4350
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Cleared under the same submission (K961524)

and 8 more cleared under K961524

Similar devices in this category

Other devices filed under Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.

Other devices from Surgistar Inc.

  • Surgistar 8191

    Class I

  • Surgistar 8119

    Class I

  • Surgistar 196469

    Class I

  • Surgistar 8120

    Class I

See all devices from Surgistar Inc. →

Properties

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