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)

NO-GAUZE LAPAROTOMY SPONGE

K-Number: K823671 · 1983-01-09

ApplicantSurgilite Intl., Inc.
Decision Date1983-01-09
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NO-GAUZE LAPAROTOMY SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Surgilite Intl., Inc.. It received FDA 510(k) clearance on 1983-01-09 under 510(k) number K823671. 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 NO-GAUZE LAPAROTOMY SPONGE?

NO-GAUZE LAPAROTOMY SPONGE is a medical device that received FDA 510(k) clearance on 1983-01-09. The listed applicant is Surgilite Intl., Inc.. The 510(k) number is K823671.

When did NO-GAUZE LAPAROTOMY SPONGE receive FDA 510(k) clearance?

NO-GAUZE LAPAROTOMY SPONGE received FDA 510(k) clearance on 1983-01-09, under 510(k) number K823671.

Who is the listed applicant for NO-GAUZE LAPAROTOMY SPONGE?

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

What is the FDA product code for NO-GAUZE LAPAROTOMY SPONGE?

The FDA product code for NO-GAUZE LAPAROTOMY SPONGE 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 Surgilite Intl., 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.

K822482SURGILITE NON-WOVEN WRAPK822483MULTIPLE SCRUB SUITK822481MULTIPLE SURGICAL MASKK771531LAPAROTOMY SPONGES

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

View on FDA Database →

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

↑