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FDA 510(k)

EDWARDS-WALLACE BOURNE HALL CATHETER

K-Number: K910577 · 1991-05-09

ApplicantMarlo Surgical Technology
Decision Date1991-05-09
Product CodeMFD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EDWARDS-WALLACE BOURNE HALL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Marlo Surgical Technology. It received FDA 510(k) clearance on 1991-05-09 under 510(k) number K910577. The device is classified under product code MFD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDWARDS-WALLACE BOURNE HALL CATHETER?

EDWARDS-WALLACE BOURNE HALL CATHETER is a medical device that received FDA 510(k) clearance on 1991-05-09. The listed applicant is Marlo Surgical Technology. The 510(k) number is K910577.

When did EDWARDS-WALLACE BOURNE HALL CATHETER receive FDA 510(k) clearance?

EDWARDS-WALLACE BOURNE HALL CATHETER received FDA 510(k) clearance on 1991-05-09, under 510(k) number K910577.

Who is the listed applicant for EDWARDS-WALLACE BOURNE HALL CATHETER?

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

What is the FDA product code for EDWARDS-WALLACE BOURNE HALL CATHETER?

The FDA product code for EDWARDS-WALLACE BOURNE HALL CATHETER is MFD.

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Other records listing Marlo Surgical Technology 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.

K960810BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MMK962273MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NSTK924611IRRIGATION PUMP AND TUBING SETK932634NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURESK932832PRIMUS INSULATED FORCEPSK920611MARLOW LAPAROSCOPIC GRASPING FORCEP

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Related Devices (Code: MFD)

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.

K021438INSEMINATION CATHETER, MODEL 320301Labotect Labor-Technik GottingenK012935THECURVE, ITEM 507Select Medical Systems, Inc.K984306`THE INSEMINATOR' (PROPOSED)Wallach Surgical Devices, Inc.K982630MEDWORKS VISUALIZATION INSEMINATION CATHETERMedworks Corp.K982628MEDWORKS INSEMINATION CATHETERMedworks Corp.K980061EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTERRocket Medical Plc

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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