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FDA 510(k)

MANIPULATOR & INJECTOR, UTERINE

K-Number: K770727 · 1977-04-26

ApplicantNational Catheter Co. Div. Mallinckrodt
Decision Date1977-04-26
Product CodeKNA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MANIPULATOR & INJECTOR, UTERINE is the device name listed in this FDA 510(k) record. The listed applicant is National Catheter Co. Div. Mallinckrodt. It received FDA 510(k) clearance on 1977-04-26 under 510(k) number K770727. 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 MANIPULATOR & INJECTOR, UTERINE?

MANIPULATOR & INJECTOR, UTERINE is a medical device that received FDA 510(k) clearance on 1977-04-26. The listed applicant is National Catheter Co. Div. Mallinckrodt. The 510(k) number is K770727.

When did MANIPULATOR & INJECTOR, UTERINE receive FDA 510(k) clearance?

MANIPULATOR & INJECTOR, UTERINE received FDA 510(k) clearance on 1977-04-26, under 510(k) number K770727.

Who is the listed applicant for MANIPULATOR & INJECTOR, UTERINE?

The FDA 510(k) record lists National Catheter Co. Div. Mallinckrodt as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANIPULATOR & INJECTOR, UTERINE?

The FDA product code for MANIPULATOR & INJECTOR, UTERINE is KNA.

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Other records listing National Catheter Co. Div. Mallinckrodt 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.

K802918ANTHRON CATHETER SETK802505DOUBLE LUMEN TRACHEAL TUBEK810321REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)K801924HI-LO TEMP GEN. PURPOSE TEMP. PROBEK801005MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)K791190STETHOSCOPE WITH TEMPERATURE SENSOR

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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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