Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000

K-Number: K863089 · 1986-10-14

ApplicantLifestream Int'L, Inc.
Decision Date1986-10-14
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 is the device name listed in this FDA 510(k) record. The listed applicant is Lifestream Int'L, Inc.. It received FDA 510(k) clearance on 1986-10-14 under 510(k) number K863089. 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 DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000?

DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 is a medical device that received FDA 510(k) clearance on 1986-10-14. The listed applicant is Lifestream Int'L, Inc.. The 510(k) number is K863089.

When did DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 receive FDA 510(k) clearance?

DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 received FDA 510(k) clearance on 1986-10-14, under 510(k) number K863089.

Who is the listed applicant for DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000?

The FDA 510(k) record lists Lifestream Int'L, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000?

The FDA product code for DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 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 Lifestream Int'L, 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.

K964571VISION CARDIOPLEGIA DELIVERY SYSTEMK962354DIOMED 15, 30, 60 SURGICAL DIODE LASERK920178CARDIOTOMY RESERVOIR W/20 MICRON FILITERK920618AUTOTRANSFUSION SUCTION SETK913181AUTOLOGOUS BLOOD PROCESSING SYSTEMK914396SURGI LIGHT NON-CONTACT FIBERS

View all 23 devices →

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.K953059KITTNER DISSECTORMedical Perspectives Corp.

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.

↑