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)

IRRIGATING NEEDLE, ILLUMINATED

K-Number: K771785 · 1977-11-29

ApplicantConcept, Inc.
Decision Date1977-11-29
Product Code
DecisionSubstantially Equivalent

Device Summary

IRRIGATING NEEDLE, ILLUMINATED is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1977-11-29 under 510(k) number K771785. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATING NEEDLE, ILLUMINATED?

IRRIGATING NEEDLE, ILLUMINATED is a medical device that received FDA 510(k) clearance on 1977-11-29. The listed applicant is Concept, Inc.. The 510(k) number is K771785.

When did IRRIGATING NEEDLE, ILLUMINATED receive FDA 510(k) clearance?

IRRIGATING NEEDLE, ILLUMINATED received FDA 510(k) clearance on 1977-11-29, under 510(k) number K771785.

Who is the listed applicant for IRRIGATING NEEDLE, ILLUMINATED?

The FDA 510(k) record lists Concept, 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 Concept, 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.

K912640CONCEPT ENDOSTEAL FIXATION DEVICEK912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

View all 83 devices →

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.

↑