Piezo Handpiece

FDA 510(k) K902150 · United Surgical Corp.

Substantially Equivalent

510(k) numberK902150

Submission

Device name
Piezo Handpiece
Applicant
United Surgical Corp.
Irvine, CA, US
Received
May 15, 1990
Decision date
July 5, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HQC – Unit, Phacofragmentation
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4670
Specialty
Ophthalmic

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Questions and answers

When was Piezo Handpiece cleared by the FDA?

Piezo Handpiece (K902150) received a 510(k) decision of Substantially Equivalent on July 5, 1990, 51 days after the submission was received.

What is the product code of K902150?

The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.