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)

SMART DILATOR

K-Number: K082995 · 2009-02-06

ApplicantSafestitch Medical
Decision Date2009-02-06
Product CodeKNQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SMART DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Safestitch Medical. It received FDA 510(k) clearance on 2009-02-06 under 510(k) number K082995. The device is classified under product code KNQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMART DILATOR?

SMART DILATOR is a medical device that received FDA 510(k) clearance on 2009-02-06. The listed applicant is Safestitch Medical. The 510(k) number is K082995.

When did SMART DILATOR receive FDA 510(k) clearance?

SMART DILATOR received FDA 510(k) clearance on 2009-02-06, under 510(k) number K082995.

Who is the listed applicant for SMART DILATOR?

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

What is the FDA product code for SMART DILATOR?

The FDA product code for SMART DILATOR is KNQ.

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

Related Devices (Code: KNQ)

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.

K122924CRE FIXED WIRE BALLON DILATION CATHETERBoston Scientific CorpK093236ETHICON ENDO-SURGERYOPTICAL DILATOREthicon Endo-Surgery, Inc.K090183HERCULES 3 STAGE WIRE GUIDED DILATION BALLOONCook EndoscopyK061937COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOONCook EndoscopyK061787MAXFORCE TTS SINGLE-USE BALLOON DILATORBoston Scientific CorpK060302INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDEDCordis Europa, N.V.

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.

↑