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FDA 510(k)

LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36

K-Number: K864529 · 1986-12-16

ApplicantElof Hansson, Inc.
Decision Date1986-12-16
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36 is the device name listed in this FDA 510(k) record. The listed applicant is Elof Hansson, Inc.. It received FDA 510(k) clearance on 1986-12-16 under 510(k) number K864529. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36?

LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36 is a medical device that received FDA 510(k) clearance on 1986-12-16. The listed applicant is Elof Hansson, Inc.. The 510(k) number is K864529.

When did LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36 receive FDA 510(k) clearance?

LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36 received FDA 510(k) clearance on 1986-12-16, under 510(k) number K864529.

Who is the listed applicant for LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36?

The FDA 510(k) record lists Elof Hansson, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36?

The FDA product code for LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36 is GDY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Elof Hansson, Inc. 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.

K864528TOWELS

Related Devices (Code: GDY)

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.

K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.K960236CPR LAP SPONGESCustom Pack ReliabilityK955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.K953830KENSORBKentron Health Care, Inc.K953058ROUND STICK SPONGES, FLAT STICK SPONGESMedical Perspectives Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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