510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NKXClass II

Needle, Phacoemulsification, Reprocessed

21 CFR 886.4670 / Ophthalmic
FDA source (opens on fda.gov)

NKX is the FDA product code for Needle, Phacoemulsification, Reprocessed, a class II device type, regulated under 21 CFR 886.4670. FDA's definition for this code reads: "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...". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
NKX
Device name
Needle, Phacoemulsification, Reprocessed
FDA definition
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).
Regulation
21 CFR 886.4670
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
5
Ingested recalls
11

Clearances, product code NKX

By decision year
5 clearances under product code NKX with a decision year between 2001 and 2007, 2001 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NKX by decision year
YearClearances
20012
20031
20051
20071

Applicants with the most clearances

Product code NKX
Applicants holding the most 510(k) clearances under product code NKX
ApplicantClearances
Alliance Medical Corp.2
Sterilmed Inc1
Surgical Instruments Service and Savings, Inc.1
Stryker Sustainability Solutions1

Companies listing this code with FDA

Companies whose registered establishments list this code