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)

SPONGES STERILE TWIN PAKT AND SINGLES

K-Number: K863737 · 1986-10-14

ApplicantHermitage Hospital Products, Inc.
Decision Date1986-10-14
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

SPONGES STERILE TWIN PAKT AND SINGLES is the device name listed in this FDA 510(k) record. The listed applicant is Hermitage Hospital Products, Inc.. It received FDA 510(k) clearance on 1986-10-14 under 510(k) number K863737. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPONGES STERILE TWIN PAKT AND SINGLES?

SPONGES STERILE TWIN PAKT AND SINGLES is a medical device that received FDA 510(k) clearance on 1986-10-14. The listed applicant is Hermitage Hospital Products, Inc.. The 510(k) number is K863737.

When did SPONGES STERILE TWIN PAKT AND SINGLES receive FDA 510(k) clearance?

SPONGES STERILE TWIN PAKT AND SINGLES received FDA 510(k) clearance on 1986-10-14, under 510(k) number K863737.

Who is the listed applicant for SPONGES STERILE TWIN PAKT AND SINGLES?

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

What is the FDA product code for SPONGES STERILE TWIN PAKT AND SINGLES?

The FDA product code for SPONGES STERILE TWIN PAKT AND SINGLES is EFQ.

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 Hermitage Hospital Products, 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.

K941802OR TOWELK923115CLINISORBK923116COMBINE II WETPROOF PADK891324HERMITEX SPONGEK843788CUSTOM BURN DRESSING KITK822987DRESSING SPONGE

View all 8 devices →

Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, Inc.

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.

↑