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FDA 510(k)

CYSTOTOMES

K-Number: K790244 · 1979-02-12

ApplicantVisitec Co.
Decision Date1979-02-12
Product CodeHNY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CYSTOTOMES is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1979-02-12 under 510(k) number K790244. The device is classified under product code HNY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYSTOTOMES?

CYSTOTOMES is a medical device that received FDA 510(k) clearance on 1979-02-12. The listed applicant is Visitec Co.. The 510(k) number is K790244.

When did CYSTOTOMES receive FDA 510(k) clearance?

CYSTOTOMES received FDA 510(k) clearance on 1979-02-12, under 510(k) number K790244.

Who is the listed applicant for CYSTOTOMES?

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 CYSTOTOMES?

The FDA product code for CYSTOTOMES is HNY.

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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: HNY)

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.

K961524STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORSSterilab, Inc.K880345CYSTOTOMES/KNIFESMyocure, Inc.K874975PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOMEAdvanced Surgical Products, Inc.K874983PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874997PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874993PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOMEAdvanced Surgical Products, 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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