510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950569Substantially Equivalent

Ophta Sil {Self-Threading Monoka (Ritleng Type)}

G.W.B. Intl., Ltd., Marshfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950569 is the FDA 510(k) clearance record for OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}, cleared for G.W.B. Intl., Ltd. on under FDA product code LZU (Plug, Punctum). FDA records list 8 510(k) clearances for G.W.B. Intl., Ltd., from to . As of , FDA records show no recalls naming K950569.

Clearance record

Decision date
Received
(41 days to decision)
Product code
LZU Plug, Punctum
Device class
Unclassified
Review panel
Unknown
Applicant
G.W.B. Intl., Ltd. P.O. Box 465, Marshfield MA
510(k) summary
Statement
Third party review
No

Clearances, product code LZU

Trailing 12 months

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

FDA records show no clearances under product code LZU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LZU, 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