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FDA 510(k)

CYSTOTOMES/KNIFES

K-Number: K880345 · 1988-05-03

ApplicantMyocure, Inc.
Decision Date1988-05-03
Product CodeHNY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CYSTOTOMES/KNIFES is the device name listed in this FDA 510(k) record. The listed applicant is Myocure, Inc.. It received FDA 510(k) clearance on 1988-05-03 under 510(k) number K880345. 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/KNIFES?

CYSTOTOMES/KNIFES is a medical device that received FDA 510(k) clearance on 1988-05-03. The listed applicant is Myocure, Inc.. The 510(k) number is K880345.

When did CYSTOTOMES/KNIFES receive FDA 510(k) clearance?

CYSTOTOMES/KNIFES received FDA 510(k) clearance on 1988-05-03, under 510(k) number K880345.

Who is the listed applicant for CYSTOTOMES/KNIFES?

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

What is the FDA product code for CYSTOTOMES/KNIFES?

The FDA product code for CYSTOTOMES/KNIFES is HNY.

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Other records listing Myocure, Inc. 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.

K880347ANESTHESIA/RETROBULBAR NEEDLESK880346CANNULASK874057OPHTHALMIC TIP & BLADE SCALPELSK874056OPHTHALMIC DISPOSABLE BLADESK873385OPHTHALMIC PHACO-BLADEK864371SURGICAL SKIN MARKER

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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.K875001PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874993PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874997PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874983PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874975PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. 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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