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)

DISPOSABLE CYSTOTOME

K-Number: K830040 · 1983-02-07

ApplicantContemporary Surgical Systems, Inc.
Decision Date1983-02-07
Product CodeHNY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE CYSTOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Contemporary Surgical Systems, Inc.. It received FDA 510(k) clearance on 1983-02-07 under 510(k) number K830040. 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 DISPOSABLE CYSTOTOME?

DISPOSABLE CYSTOTOME is a medical device that received FDA 510(k) clearance on 1983-02-07. The listed applicant is Contemporary Surgical Systems, Inc.. The 510(k) number is K830040.

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

DISPOSABLE CYSTOTOME received FDA 510(k) clearance on 1983-02-07, under 510(k) number K830040.

Who is the listed applicant for DISPOSABLE CYSTOTOME?

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

What is the FDA product code for DISPOSABLE CYSTOTOME?

The FDA product code for DISPOSABLE 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 Contemporary Surgical Systems, 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.

K800110X-FLOK791917X-PAK

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.

↑