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FDA 510(k)

STERILIZED DISPOS. CYSTOTOME

K-Number: K840442 · 1984-03-16

ApplicantMicrosurgical Technology, Inc.
Decision Date1984-03-16
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STERILIZED DISPOS. CYSTOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Microsurgical Technology, Inc.. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K840442. The device is classified under product code HMX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILIZED DISPOS. CYSTOTOME?

STERILIZED DISPOS. CYSTOTOME is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Microsurgical Technology, Inc.. The 510(k) number is K840442.

When did STERILIZED DISPOS. CYSTOTOME receive FDA 510(k) clearance?

STERILIZED DISPOS. CYSTOTOME received FDA 510(k) clearance on 1984-03-16, under 510(k) number K840442.

Who is the listed applicant for STERILIZED DISPOS. CYSTOTOME?

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

What is the FDA product code for STERILIZED DISPOS. CYSTOTOME?

The FDA product code for STERILIZED DISPOS. CYSTOTOME is HMX.

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Other records listing Microsurgical Technology, Inc. as applicant

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Related Devices (Code: HMX)

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.

K010305WEISS RETINAL CANNULAMicron Surgical, Inc.K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIESRetinalabs.ComK970873ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)American Medical Devices, Inc.K943932STERISEAL OPHTHALMIC CANNULAPharma-Plast, Ltd.K942403INFUSION CANNULAMicrosurgical Technology, Inc.K934844INTER TIP TMicrosurgical Technology, 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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