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FDA 510(k)

OPHTHALMIC PHACO-BLADE

K-Number: K873385 · 1987-09-21

ApplicantMyocure, Inc.
Decision Date1987-09-21
Product CodeHNN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC PHACO-BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Myocure, Inc.. It received FDA 510(k) clearance on 1987-09-21 under 510(k) number K873385. The device is classified under product code HNN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMIC PHACO-BLADE?

OPHTHALMIC PHACO-BLADE is a medical device that received FDA 510(k) clearance on 1987-09-21. The listed applicant is Myocure, Inc.. The 510(k) number is K873385.

When did OPHTHALMIC PHACO-BLADE receive FDA 510(k) clearance?

OPHTHALMIC PHACO-BLADE received FDA 510(k) clearance on 1987-09-21, under 510(k) number K873385.

Who is the listed applicant for OPHTHALMIC PHACO-BLADE?

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 OPHTHALMIC PHACO-BLADE?

The FDA product code for OPHTHALMIC PHACO-BLADE is HNN.

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 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.

K880345CYSTOTOMES/KNIFESK880346CANNULASK880347ANESTHESIA/RETROBULBAR NEEDLESK874057OPHTHALMIC TIP & BLADE SCALPELSK874056OPHTHALMIC DISPOSABLE BLADESK864371SURGICAL SKIN MARKER

View all 15 devices →

Related Devices (Code: HNN)

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.

K110166CLEARCUT S SAFETY KNIFEAlcon Research, Ltd.K922378OPHTHALMIC KNIFEMicroptics Development LaboratoryK882402RETRACTIVE INCISION MICROMETER (RIM) GUAGEOptical CenterK881669MVR/STILETTO BLADE 20GA. - P/N 1900Advanced Surgical Products, Inc.K874979PRISMA DISPOSABLE MVR/STILETTO BLADEAdvanced Surgical Products, Inc.K874057OPHTHALMIC TIP & BLADE SCALPELSMyocure, 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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