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FDA 510(k)

UTERINE MANIPULATORS

K-Number: K812204 · 1981-10-13

ApplicantReznik Instruments
Decision Date1981-10-13
Product CodeKOH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

UTERINE MANIPULATORS is the device name listed in this FDA 510(k) record. The listed applicant is Reznik Instruments. It received FDA 510(k) clearance on 1981-10-13 under 510(k) number K812204. The device is classified under product code KOH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UTERINE MANIPULATORS?

UTERINE MANIPULATORS is a medical device that received FDA 510(k) clearance on 1981-10-13. The listed applicant is Reznik Instruments. The 510(k) number is K812204.

When did UTERINE MANIPULATORS receive FDA 510(k) clearance?

UTERINE MANIPULATORS received FDA 510(k) clearance on 1981-10-13, under 510(k) number K812204.

Who is the listed applicant for UTERINE MANIPULATORS?

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 UTERINE MANIPULATORS?

The FDA product code for UTERINE MANIPULATORS is KOH.

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 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 EQUIPMENTK812203ELECTROSURGICAL UNITK812199TROCAR & TROCAR SLEEVESK812206LAPAROSCOPEK812200INSUFFLATOR

View all 9 devices →

Related Devices (Code: KOH)

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.

K000212KSEA CHARDONNES MORCELLATION KNIFEKARL STORZ Endoscopy-America, Inc.K921730C-SECTION PACKMedikmark, Inc.K921732MINOR LAP SETMedikmark, Inc.K892693VAGINAL SPECULA: CUSCO, GUTTMAN, INFANTZinnanti Surgical Instruments, Inc.K891351NEWPORT LATERAL VAGINAL RETRACTORSimpson/Basye, Inc.K891035NEEDLE EXTENSIONSZinnanti Surgical Instruments, 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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