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 DISSECTOR SPONGES-X-RAY DETECT

K-Number: K812707 · 1981-11-02

ApplicantMedspec Corp.
Decision Date1981-11-02
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE DISSECTOR SPONGES-X-RAY DETECT is the device name listed in this FDA 510(k) record. The listed applicant is Medspec Corp.. It received FDA 510(k) clearance on 1981-11-02 under 510(k) number K812707. 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 DISSECTOR SPONGES-X-RAY DETECT?

STERILE DISSECTOR SPONGES-X-RAY DETECT is a medical device that received FDA 510(k) clearance on 1981-11-02. The listed applicant is Medspec Corp.. The 510(k) number is K812707.

When did STERILE DISSECTOR SPONGES-X-RAY DETECT receive FDA 510(k) clearance?

STERILE DISSECTOR SPONGES-X-RAY DETECT received FDA 510(k) clearance on 1981-11-02, under 510(k) number K812707.

Who is the listed applicant for STERILE DISSECTOR SPONGES-X-RAY DETECT?

The FDA 510(k) record lists Medspec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE DISSECTOR SPONGES-X-RAY DETECT?

The FDA product code for STERILE DISSECTOR SPONGES-X-RAY DETECT 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 Medspec Corp. 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.

K813012STERILE BASIN SETSK812711STERILE GAUZE PADS 12PLYK812710STERILE LAPAROTOMY SPONGES-X-RAY DETECTK812709STERILE DENTAL ROLLK810071STERILE SILICONE TUBINGK810069STERILE AIRWAY

View all 15 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.

↑