Injector, Capsular Tension Ring
The Capsular Tension Ring Injector is an ophthalmic surgical instrument used to insert a capsular tension ring (CTR) into the lens capsule during cataract surgery, providing equatorial support to the capsular bag in cases of zonular weakness or dehiscence. Classified as FDA Class 1, it is subject to general controls under regulation 886.4300 (Ophthalmic specialty). This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- NCE
- Device Class
- FDA class 1
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K042478 | CAPSULE TENSION RING INSERTER, MODEL 7-810 | Dec 28, 2004 | Substantially Equivalent | Duckworth & Kent, Ltd. |
| K011498 | EASY CONTROL MICRO INSERTER, MODEL ON385 | Jul 09, 2001 | Substantially Equivalent | Ophtec USA, Inc. |
| K001125 | GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING | Oct 04, 2000 | Substantially Equivalent | Geuder GmbH |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.