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FDA 510(k)

OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT

K-Number: K864623 · 1987-01-14

ApplicantXanmed Corp.
Decision Date1987-01-14
Product CodeKNA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Xanmed Corp.. It received FDA 510(k) clearance on 1987-01-14 under 510(k) number K864623. The device is classified under product code KNA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT?

OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT is a medical device that received FDA 510(k) clearance on 1987-01-14. The listed applicant is Xanmed Corp.. The 510(k) number is K864623.

When did OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT receive FDA 510(k) clearance?

OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT received FDA 510(k) clearance on 1987-01-14, under 510(k) number K864623.

Who is the listed applicant for OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT?

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

What is the FDA product code for OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT?

The FDA product code for OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT is KNA.

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Other records listing Xanmed Corp. 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.

K844595ORTHOPEDIC CUSTOM SURGICAL KITK844596EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KITK844593CARDIOVASCULAR CUSTOM SURGICAL KITK844594NEURO CUSTOM SURGICAL KITK851906SURGICAL EYE PACKK844597MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT

View all 9 devices →

Related Devices (Code: KNA)

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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)Cook Urological, Inc.K093904GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETERGlenveigh Surgical, LLCK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400Cook Urological, Inc.K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500Cook Ob/GynK060289EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01Frontline MedicalK013597TAMPONADE UTERINE BALLOON CATHETER SETCook Ob/Gyn

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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