510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030471Substantially Equivalent

Ophtec Enclavation Needle

Ophtec USA, Inc., Boca Raton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030471 is the FDA 510(k) clearance record for OPHTEC ENCLAVATION NEEDLE, a class I device, cleared for Ophtec, USA on under FDA product code HNQ (Hook, Ophthalmic). FDA records list 2 510(k) clearances for Ophtec, USA, from to . As of , FDA records show no recalls naming K030471.

Clearance record

Decision date
Received
(64 days to decision)
Product code
HNQ Hook, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Ophtec, USA 6421 Congress Ave., Suite 112, Boca Raton FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HNQ

Trailing 12 months

FDA records hold no clearances under product code HNQ in the trailing twelve months.

FDA records show no clearances under product code HNQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HNQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260