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)

ENDOSCOPIC ELASTIC BAND LIGATOR

K-Number: K880648 · 1988-04-06

ApplicantSuperior Healthcare Group, Inc.
Decision Date1988-04-06
Product CodeFHN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC ELASTIC BAND LIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Superior Healthcare Group, Inc.. It received FDA 510(k) clearance on 1988-04-06 under 510(k) number K880648. The device is classified under product code FHN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC ELASTIC BAND LIGATOR?

ENDOSCOPIC ELASTIC BAND LIGATOR is a medical device that received FDA 510(k) clearance on 1988-04-06. The listed applicant is Superior Healthcare Group, Inc.. The 510(k) number is K880648.

When did ENDOSCOPIC ELASTIC BAND LIGATOR receive FDA 510(k) clearance?

ENDOSCOPIC ELASTIC BAND LIGATOR received FDA 510(k) clearance on 1988-04-06, under 510(k) number K880648.

Who is the listed applicant for ENDOSCOPIC ELASTIC BAND LIGATOR?

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

What is the FDA product code for ENDOSCOPIC ELASTIC BAND LIGATOR?

The FDA product code for ENDOSCOPIC ELASTIC BAND LIGATOR is FHN.

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 Superior Healthcare Group, 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.

K925530INSTRUMENT WARMERK924764OVERTUBE FOR ENDSCOPIC LIGATORK905755NON-STERILE PATIENT EXAMINATION GLOVESK903347SODIUM CHLORIDE SOLUTIONK904216STERILE WATER SOLUTION CATALOG # 10000K903340STERILE URETHRAL CATHETER PROCEDURE KITS

View all 14 devices →

Related Devices (Code: FHN)

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.

K213223Multi-Band LigatorBeijing Zksk Technology Co., Ltd.K172985Ligation DeviceLeo Medical Co., Ltd.K131282NEXUS HEMORRHOID LIGATORInx MedicalK093497THD BANDYThd SpaK091519HAEMOBAND MULTI-LIGATORHaemoband Surgical, Ltd.K070881LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660Sapimed S.P.A.

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.

↑