FDA 510(k)

AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS

K-Number: K121426 · 2012-07-10

Decision Date2012-07-10

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Synergetics, Inc.. It received FDA 510(k) clearance on 2012-07-10 under 510(k) number K121426. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS?

AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS is a medical device that received FDA 510(k) clearance on 2012-07-10. The listed applicant is Synergetics, Inc.. The 510(k) number is K121426.

When did AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS receive FDA 510(k) clearance?

AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS received FDA 510(k) clearance on 2012-07-10, under 510(k) number K121426.

Who is the listed applicant for AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS?

The FDA 510(k) record lists Synergetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS?

The FDA product code for AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS is GEI.

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Other records listing Synergetics, Inc. as applicant

K121675VERSAVIT K113857SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE K110924DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS K091441SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET K071482STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 K063489STRYKER INTRADISCAL RF GENERATOR

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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.