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)

STERILE GAUZE SPONGES X-RAY DETECTABLE

K-Number: K922054 · 1992-08-10

ApplicantTeam Mfg., Inc.
Decision Date1992-08-10
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE GAUZE SPONGES X-RAY DETECTABLE is the device name listed in this FDA 510(k) record. The listed applicant is Team Mfg., Inc.. It received FDA 510(k) clearance on 1992-08-10 under 510(k) number K922054. 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 STERILE GAUZE SPONGES X-RAY DETECTABLE?

STERILE GAUZE SPONGES X-RAY DETECTABLE is a medical device that received FDA 510(k) clearance on 1992-08-10. The listed applicant is Team Mfg., Inc.. The 510(k) number is K922054.

When did STERILE GAUZE SPONGES X-RAY DETECTABLE receive FDA 510(k) clearance?

STERILE GAUZE SPONGES X-RAY DETECTABLE received FDA 510(k) clearance on 1992-08-10, under 510(k) number K922054.

Who is the listed applicant for STERILE GAUZE SPONGES X-RAY DETECTABLE?

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

What is the FDA product code for STERILE GAUZE SPONGES X-RAY DETECTABLE?

The FDA product code for STERILE GAUZE SPONGES X-RAY DETECTABLE 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 Team Mfg., 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.

K922055STERILE AND NON-STERILE GAUZE SPONGESK904934AUTOMASTER

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.

↑