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FDA 510(k)

MICRO SURGICAL HANDLE

K-Number: K831996 · 1983-07-12

ApplicantVisitec Co.
Decision Date1983-07-12
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MICRO SURGICAL HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1983-07-12 under 510(k) number K831996. The device is classified under product code KYG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO SURGICAL HANDLE?

MICRO SURGICAL HANDLE is a medical device that received FDA 510(k) clearance on 1983-07-12. The listed applicant is Visitec Co.. The 510(k) number is K831996.

When did MICRO SURGICAL HANDLE receive FDA 510(k) clearance?

MICRO SURGICAL HANDLE received FDA 510(k) clearance on 1983-07-12, under 510(k) number K831996.

Who is the listed applicant for MICRO SURGICAL HANDLE?

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

What is the FDA product code for MICRO SURGICAL HANDLE?

The FDA product code for MICRO SURGICAL HANDLE is KYG.

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Other records listing Visitec Co. 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.

K953394VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}K945114VISITEC SCLERAL PLUGK945738VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPEK945172VISITEC SILICONE RETINAL IMPLANTS/EXPLANTSK942234VISITEC PRECISE-POINTK934269FIBEROPTIC ILLUMINATED INSTRUMENTS

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Related Devices (Code: KYG)

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.

K010353MED-LOGICS DISPOSABLE ALK TUBINGMed-Logics, Inc.K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Retinalabs.ComK993591BLADEWORKS DISPOSABLE ALK TUBINGBlade Works, Inc.K981116SOVEREIGN CATARACT EXTRACTION SYSTEMAllergan, Inc.K980647EYE IRRIGATOR MODEL #2020Eye-Deal Ocular Safety Products, Inc.K974561MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, Inc.

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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