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510(k) K001125

GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING by Geuder GmbH — Product Code NCE

K001125 is an FDA 510(k) premarket notification submitted by Geuder GmbH for the device "GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING". The FDA issued a decision of Substantially Equivalent on October 4, 2000. The device falls under product code NCE (Injector, Capsular Tension Ring), a Class I device regulated under 21 CFR 886.4300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2000
Date Received
April 7, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Capsular Tension Ring
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type

Other clearances for product code NCE

  • K042478 — CAPSULE TENSION RING INSERTER, MODEL 7-810 (December 28, 2004)
  • K011498 — EASY CONTROL MICRO INSERTER, MODEL ON385 (July 9, 2001)

FDA data resources