Site Phaco Plus Infusion Sleeve

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K892852 ↗

FDA Product Code

HQC

Device Class

Class II

Regulation

21 CFR Part 886.4670

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• 180 Tip, 1/A Handpiece .3MM End Opening for Opht.

  Class II

  FDA 510(k) K920582 Active Cleared 8 May 1992

• Modified Site Txr Systems

  Class II

  FDA 510(k) K925828 Active Cleared 16 Feb 1994

• Site Phacoemulsification Handpiece

  Class II

  FDA 510(k) K904183 Active Cleared 5 Dec 1990

• Modified Site Peristaltic Footswitch

  Class I

  FDA 510(k) K905620 Active Cleared 27 Feb 1991

• Site Diaphragm Cassette

  Class I

  FDA 510(k) K904186 Active Cleared 21 Nov 1990

• Phacoemulsification System for Ophthalmic Use

  Class II

  FDA 510(k) K912902 Active Cleared 17 Dec 1991

See all devices from Site Microsurgical Systems, Inc. →

• What is the primary use of the Site Phaco Plus Infusion Sleeve in cataract surgery?

  The Site Phaco Plus Infusion Sleeve is designed to facilitate phacofragmentation during cataract surgery by using ultrasound energy to break down cataracts. It also integrates with infusion systems to help maintain intraocular pressure throughout the procedure, ensuring stability and safety during the operation.

• Is the Site Phaco Plus Infusion Sleeve intended for single-use or reusable applications?

  The Site Phaco Plus Infusion Sleeve is explicitly labeled as a single-use, sterile device. It is part of a reusable phacofragmentation system but must not be reused after a single procedure to preserve sterility and patient safety.

• How should the Site Phaco Plus Infusion Sleeve be stored to maintain its sterility?

  Since the device is single-use and sterile, it must be stored in its original packaging until the moment of use. Proper handling and storage instructions provided by the manufacturer should be followed to ensure sterility is maintained, as reusing or improperly storing it could compromise its integrity.

• What regulatory pathway was followed for FDA clearance of the Site Phaco Plus Infusion Sleeve?

  The Site Phaco Plus Infusion Sleeve received FDA clearance through a Traditional 510(k) pathway, with a decision classification of *Substantially Equivalent* (SESE). The device was reviewed by the Ophthalmic (OP) Advisory Committee and falls under FDA regulation 886.4670 as a Class II medical device.