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FDA 510(k)

ACCESSORIES(PROBES, SUCTION TUBES, ETC.)

K-Number: K812198 · 1981-09-11

ApplicantReznik Instruments
Decision Date1981-09-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCESSORIES(PROBES, SUCTION TUBES, ETC.) is the device name listed in this FDA 510(k) record. The listed applicant is Reznik Instruments. It received FDA 510(k) clearance on 1981-09-11 under 510(k) number K812198. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESSORIES(PROBES, SUCTION TUBES, ETC.)?

ACCESSORIES(PROBES, SUCTION TUBES, ETC.) is a medical device that received FDA 510(k) clearance on 1981-09-11. The listed applicant is Reznik Instruments. The 510(k) number is K812198.

When did ACCESSORIES(PROBES, SUCTION TUBES, ETC.) receive FDA 510(k) clearance?

ACCESSORIES(PROBES, SUCTION TUBES, ETC.) received FDA 510(k) clearance on 1981-09-11, under 510(k) number K812198.

Who is the listed applicant for ACCESSORIES(PROBES, SUCTION TUBES, ETC.)?

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

What is the FDA product code for ACCESSORIES(PROBES, SUCTION TUBES, ETC.)?

The FDA product code for ACCESSORIES(PROBES, SUCTION TUBES, ETC.) is GEI.

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Other records listing Reznik Instruments 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.

K812205FORCEPK812201PHOTOGRAPHIC EQUIPMENTK812204UTERINE MANIPULATORSK812203ELECTROSURGICAL UNITK812199TROCAR & TROCAR SLEEVESK812206LAPAROSCOPE

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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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