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FDA 510(k)

CAPSULE TENSION RING INSERTER, MODEL 7-810

K-Number: K042478 · 2004-12-28

ApplicantDuckworth & Kent, Ltd.
Decision Date2004-12-28
Product CodeNCE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CAPSULE TENSION RING INSERTER, MODEL 7-810 is the device name listed in this FDA 510(k) record. The listed applicant is Duckworth & Kent, Ltd.. It received FDA 510(k) clearance on 2004-12-28 under 510(k) number K042478. The device is classified under product code NCE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPSULE TENSION RING INSERTER, MODEL 7-810?

CAPSULE TENSION RING INSERTER, MODEL 7-810 is a medical device that received FDA 510(k) clearance on 2004-12-28. The listed applicant is Duckworth & Kent, Ltd.. The 510(k) number is K042478.

When did CAPSULE TENSION RING INSERTER, MODEL 7-810 receive FDA 510(k) clearance?

CAPSULE TENSION RING INSERTER, MODEL 7-810 received FDA 510(k) clearance on 2004-12-28, under 510(k) number K042478.

Who is the listed applicant for CAPSULE TENSION RING INSERTER, MODEL 7-810?

The FDA 510(k) record lists Duckworth & Kent, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPSULE TENSION RING INSERTER, MODEL 7-810?

The FDA product code for CAPSULE TENSION RING INSERTER, MODEL 7-810 is NCE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Duckworth & Kent, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K081382DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786K072985DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2K060995DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788K053176DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797K024072DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM

Related Devices (Code: NCE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K011498EASY CONTROL MICRO INSERTER, MODEL ON385Ophtec USA, Inc.K001125GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RINGGeuder GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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