510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200242Substantially Equivalent

StaClear Syringe

Tribofilm Research, Inc., Raleigh NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200242 is the FDA 510(k) clearance record for StaClear Syringe, a class II device, cleared for Tribofilm Research, Inc. on under FDA product code QLY (Ophthalmic Syringe). FDA's definition for product code QLY reads: "An Ophthalmic Syringe is a piston syringe intended for intraocular injections. The device consists of a calibrated hollow barrel, a movable plunger, and may include a needle. The device should be used by health care professionals to...". FDA records list 2 510(k) clearances for Tribofilm Research, Inc., from to . As of , FDA records show no recalls naming K200242.

Clearance record

Decision date
Received
(178 days to decision)
Product code
QLY Ophthalmic Syringe
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Tribofilm Research, Inc. 625 Hutton St., Raleigh NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QLY

Trailing 12 months
1 clearance under product code QLY in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QLY, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260