510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001125Substantially Equivalent

Geuder Injector for Morcher Capsular Tension Ring

Geuder AG, Centercille MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001125 is the FDA 510(k) clearance record for GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING, a class I device, cleared for Geuder GmbH on under FDA product code NCE (Injector, Capsular Tension Ring). FDA records list one 510(k) clearance for Geuder GmbH. As of , FDA records show no recalls naming K001125.

Clearance record

Decision date
Received
(180 days to decision)
Product code
NCE Injector, Capsular Tension Ring
Regulation
21 CFR 886.4300
Device class
Class I
Review panel
Ophthalmic
Applicant
Geuder GmbH 344 Annabelle Pt. Rd., Centercille MA
510(k) summary
Statement
Third party review
No

Clearances, product code NCE

Trailing 12 months

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

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