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)

CAPSULECTOMER CYSTOTOME

K-Number: K871365 · 1987-04-16

ApplicantNoetix, Inc.
Decision Date1987-04-16
Product CodeHNY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CAPSULECTOMER CYSTOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Noetix, Inc.. It received FDA 510(k) clearance on 1987-04-16 under 510(k) number K871365. The device is classified under product code HNY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPSULECTOMER CYSTOTOME?

CAPSULECTOMER CYSTOTOME is a medical device that received FDA 510(k) clearance on 1987-04-16. The listed applicant is Noetix, Inc.. The 510(k) number is K871365.

When did CAPSULECTOMER CYSTOTOME receive FDA 510(k) clearance?

CAPSULECTOMER CYSTOTOME received FDA 510(k) clearance on 1987-04-16, under 510(k) number K871365.

Who is the listed applicant for CAPSULECTOMER CYSTOTOME?

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

What is the FDA product code for CAPSULECTOMER CYSTOTOME?

The FDA product code for CAPSULECTOMER CYSTOTOME is HNY.

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 Noetix, 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.

K893992NOETIX, BIOPSY NEEDLEK881635NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM

Related Devices (Code: HNY)

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.

K961524STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORSSterilab, Inc.K880345CYSTOTOMES/KNIFESMyocure, Inc.K874975PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOMEAdvanced Surgical Products, Inc.K874983PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874997PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOMEAdvanced Surgical Products, Inc.K874993PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOMEAdvanced Surgical Products, 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.

↑