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FDA 510(k)

CRYO SURG 5900

K-Number: K840536 · 1984-04-23

ApplicantFrigitronics of Connecticut, Inc.
Decision Date1984-04-23
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYO SURG 5900 is the device name listed in this FDA 510(k) record. The listed applicant is Frigitronics of Connecticut, Inc.. It received FDA 510(k) clearance on 1984-04-23 under 510(k) number K840536. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYO SURG 5900?

CRYO SURG 5900 is a medical device that received FDA 510(k) clearance on 1984-04-23. The listed applicant is Frigitronics of Connecticut, Inc.. The 510(k) number is K840536.

When did CRYO SURG 5900 receive FDA 510(k) clearance?

CRYO SURG 5900 received FDA 510(k) clearance on 1984-04-23, under 510(k) number K840536.

Who is the listed applicant for CRYO SURG 5900?

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

What is the FDA product code for CRYO SURG 5900?

The FDA product code for CRYO SURG 5900 is GEH.

Other records listing Frigitronics of Connecticut, 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.

K891282MIC-100 WITH CRYOPROBESK872362FRIGITRONICS ACC-1000 CAPSULE CUTTERK853308KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000K834577I/A PROBE LINESK834437KEATES IRRIGATION/ASPIRATION/VITREOUSK822599KEATES I/A SYSTEM FRIGITRONICS 4000

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Related Devices (Code: GEH)

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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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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