Data / Medical devices / Instrument, Vitreous Aspiration And Cutting, Battery-Powered
Instrument, Vitreous Aspiration And Cutting, Battery-Powered (HKP): 3 FDA-registered makers in 1 country
3 establishments in 1 country are registered with the FDA to make Instrument, Vitreous Aspiration And Cutting, Battery-Powered (product code HKP, Class 2, 21 CFR 886.4150). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on March 19, 1997, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HKP
- Device class
- 2
- Regulation
- 886.4150
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
Makers of Instrument, Vitreous Aspiration And Cutting, Battery-Powered
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 1 | October 5, 1976 | 0 | 0 | 0 | api.fda.gov |
| Medical Instrument Development Laboratories, Inc. | San Leandro, CA, United States | Manufacturer | 1 | April 10, 1995 | 0 | 0 | 0 | api.fda.gov |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 19, 1997. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.