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FDA 510(k)

MANUAL OPHTHALMIC SURGICAL INSTRUMENTS

K-Number: K874963 · 1987-12-23

ApplicantSolway, Inc.
Decision Date1987-12-23
Product CodeHNA
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MANUAL OPHTHALMIC SURGICAL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Solway, Inc.. It received FDA 510(k) clearance on 1987-12-23 under 510(k) number K874963. The device is classified under product code HNA. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANUAL OPHTHALMIC SURGICAL INSTRUMENTS?

MANUAL OPHTHALMIC SURGICAL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1987-12-23. The listed applicant is Solway, Inc.. The 510(k) number is K874963.

When did MANUAL OPHTHALMIC SURGICAL INSTRUMENTS receive FDA 510(k) clearance?

MANUAL OPHTHALMIC SURGICAL INSTRUMENTS received FDA 510(k) clearance on 1987-12-23, under 510(k) number K874963.

Who is the listed applicant for MANUAL OPHTHALMIC SURGICAL INSTRUMENTS?

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

What is the FDA product code for MANUAL OPHTHALMIC SURGICAL INSTRUMENTS?

The FDA product code for MANUAL OPHTHALMIC SURGICAL INSTRUMENTS is HNA.

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Other records listing Solway, 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.

K874960CARDIOVASCULAR SURGICAL INSTRUMENTSK874962FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULASK874956SELF-RETAINING RETRACTOR FOR NEUROSURGERYK874964DENTAL HAND INSTRUMENTSK875043RONGEUR (NEUROSURGICAL INSTRUMENTS)K874966TUNING FORKS

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Related Devices (Code: HNA)

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.

K931449MSP OPHTHALMIC (EYE SPUD)Medical Sterile 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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