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FDA 510(k)

LAMANO DIRECTORS

K-Number: K894592 · 1989-09-08

ApplicantMarlo Surgical Technology
Decision Date1989-09-08
Product CodeGCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAMANO DIRECTORS 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 1989-09-08 under 510(k) number K894592. The device is classified under product code GCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAMANO DIRECTORS?

LAMANO DIRECTORS is a medical device that received FDA 510(k) clearance on 1989-09-08. The listed applicant is Marlo Surgical Technology. The 510(k) number is K894592.

When did LAMANO DIRECTORS receive FDA 510(k) clearance?

LAMANO DIRECTORS received FDA 510(k) clearance on 1989-09-08, under 510(k) number K894592.

Who is the listed applicant for LAMANO DIRECTORS?

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 LAMANO DIRECTORS?

The FDA product code for LAMANO DIRECTORS is GCM.

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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 SETK932832PRIMUS INSULATED FORCEPSK932634NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURESK920611MARLOW LAPAROSCOPIC GRASPING FORCEP

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Related Devices (Code: GCM)

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.

K203226TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MMRichard Wolf Medical Instruments CorporationK083840MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPEMsi Medserv International Deutschland GmbHK001217INSIDE VIEWMonadnock Optics, Inc.K993103ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREESRichard Wolf Medical Instruments Corp.K993445OMNISONIC ENDOSCOPIC DEFLECTOROmnisonics Medical TechnologiesK962393KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATIONKARL STORZ Endoscopy-America, 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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