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)

SYRINGE INJECTION GUN

K-Number: K862853 · 1986-08-06

ApplicantGastrotech, Inc.
Decision Date1986-08-06
Product Code
DecisionSubstantially Equivalent for Some Indications

Device Summary

SYRINGE INJECTION GUN is the device name listed in this FDA 510(k) record. The listed applicant is Gastrotech, Inc.. It received FDA 510(k) clearance on 1986-08-06 under 510(k) number K862853. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SYRINGE INJECTION GUN?

SYRINGE INJECTION GUN is a medical device that received FDA 510(k) clearance on 1986-08-06. The listed applicant is Gastrotech, Inc.. The 510(k) number is K862853.

When did SYRINGE INJECTION GUN receive FDA 510(k) clearance?

SYRINGE INJECTION GUN received FDA 510(k) clearance on 1986-08-06, under 510(k) number K862853.

Who is the listed applicant for SYRINGE INJECTION GUN?

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

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 Gastrotech, 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.

K890658SYRINGE INJECTION GUN DELIVERY KITSK890629ESOPHAGEAL OVERTUBEK883351PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBEK883336GASTROSTOMY FEEDING TUBE

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.

↑