510(k) K012579

REPROCESSED PHACO TIPS by Sterilmed, Inc. — Product Code NKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 8, 2001
Date Received: August 9, 2001
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Needle, Phacoemulsification, Reprocessed
Device Class: Class II
Regulation Number: 886.4670
Review Panel: OP
Submission Type

Needle for phacoemulsification device to remove cataractous lens. Same as needle for main phacoemulsification device and un-reprocessed needle with product code HQC, except this is a "reprocessed" needle. The Phacoemulsification device is NOT reprocessed, just the needle. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

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K153006 — Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) (June 23, 2016)
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K150357 — Reprocessed Electrophysiology Diagnostic Catheters (August 27, 2015)

510(k) K012579

Clearance Details

Device Classification

Other clearances by Sterilmed, Inc.

Other clearances for product code NKX