FDA 510(k)

OPHTHALMIC SURGICAL DRAPE

K-Number: K863662 · 1986-10-20

Decision Date1986-10-20

Product Code

DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC SURGICAL DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Myocure, Inc.. It received FDA 510(k) clearance on 1986-10-20 under 510(k) number K863662. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMIC SURGICAL DRAPE?

OPHTHALMIC SURGICAL DRAPE is a medical device that received FDA 510(k) clearance on 1986-10-20. The listed applicant is Myocure, Inc.. The 510(k) number is K863662.

When did OPHTHALMIC SURGICAL DRAPE receive FDA 510(k) clearance?

OPHTHALMIC SURGICAL DRAPE received FDA 510(k) clearance on 1986-10-20, under 510(k) number K863662.

Who is the listed applicant for OPHTHALMIC SURGICAL DRAPE?

The FDA 510(k) record lists Myocure, 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Myocure, Inc. as applicant

K880345CYSTOTOMES/KNIFES K880347ANESTHESIA/RETROBULBAR NEEDLES K880346CANNULAS K874057OPHTHALMIC TIP & BLADE SCALPELS K874056OPHTHALMIC DISPOSABLE BLADES K873385OPHTHALMIC PHACO-BLADE

View all 15 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.