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)

INTER-SHARP

K-Number: K862070 · 1986-06-17

ApplicantIntermedics Intraocular, Inc.
Decision Date1986-06-17
Product CodeHNW
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INTER-SHARP is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Intraocular, Inc.. It received FDA 510(k) clearance on 1986-06-17 under 510(k) number K862070. The device is classified under product code HNW. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTER-SHARP?

INTER-SHARP is a medical device that received FDA 510(k) clearance on 1986-06-17. The listed applicant is Intermedics Intraocular, Inc.. The 510(k) number is K862070.

When did INTER-SHARP receive FDA 510(k) clearance?

INTER-SHARP received FDA 510(k) clearance on 1986-06-17, under 510(k) number K862070.

Who is the listed applicant for INTER-SHARP?

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

What is the FDA product code for INTER-SHARP?

The FDA product code for INTER-SHARP is HNW.

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 Intermedics Intraocular, 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.

K841730BAILEY LENS SHOOTERK834543OCUCARE ULTRASOUND TIP & FREEDOM PACKK832525IRRIGATION/ASPIRATION PACK

Related Devices (Code: HNW)

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.

K841002LACHRYMAL PROBES-VARIOUSPremier Dental Products Co.K812097KOI LACREMAL HOOK & DILATORKoi, 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.

↑