AORP4000 Reusable Pak

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

510(k) Number

K931358 ↗

FDA Product Code

HQC

Device Class

Class II

Regulation

21 CFR Part 886.4670

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Ao Stylet Laryngoscope Model Sls

  Class I

  FDA 510(k) K801364 Active Cleared 17 Jun 1980

• Ultravue Blended Bifocal Lens

  Class I

  FDA 510(k) K791721 Active Cleared 23 Oct 1979

• Ao Flexible Laryngoscope, #ls-7

  Class I

  FDA 510(k) K802331 Active Cleared 10 Oct 1980

• Aoi Universal Ultrasonic Handpiece

  Class II

  FDA 510(k) K950880 Active Cleared 26 May 1995

• Model SC-6 Flexible Sigmoidoscope

  Class II

  FDA 510(k) K812965 Active Cleared 2 Nov 1981

• Phaco Tip

  Class II

  FDA 510(k) K950881 Active Cleared 6 Sep 1995

See all devices from American Optical Corp. →

• What is the AORP4000 REUSABLE PAK used for?

  The AORP4000 REUSABLE PAK is a unit used in phacofragmentation procedures within the ophthalmic specialty, designed as a reusable component in ophthalmic surgical systems to assist in cataract surgery by fragmenting the lens.

• Is the AORP4000 REUSABLE PAK sterile when supplied?

  The AORP4000 REUSABLE PAK is supplied as a non-sterile device, meaning it must be cleaned and sterilized by the healthcare facility before each use in accordance with established reprocessing protocols for reusable ophthalmic surgical instruments.

• Can the AORP4000 REUSABLE PAK be reused?

  Yes, the AORP4000 REUSABLE PAK is designed as a reusable device, as indicated by its name and description, and is intended for multiple uses after proper cleaning, disinfection, and sterilization between procedures in clinical ophthalmic settings.

• What model number identifies the AORP4000 REUSABLE PAK?

  The AORP4000 REUSABLE PAK is specifically identified by the model number AORP4000, which distinguishes it from other devices in the manufacturer’s product line and is referenced in its FDA 510(k) clearance under K931358.

• How is the AORP4000 REUSABLE PAK supplied and what are its storage implications?

  The AORP4000 REUSABLE PAK is supplied non-sterile and reusable, requiring the user to perform cleaning and sterilization prior to each use; therefore, it should be stored in a clean, dry environment suitable for reusable medical devices, with no special storage conditions indicated in the provided data.