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)

CABOT MEDICAL VARIABLE FLOW INSUFFLATOR

K-Number: K862310 · 1986-08-12

ApplicantCabot Medical Corp.
Decision Date1986-08-12
Product CodeHES
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CABOT MEDICAL VARIABLE FLOW INSUFFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cabot Medical Corp.. It received FDA 510(k) clearance on 1986-08-12 under 510(k) number K862310. The device is classified under product code HES. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CABOT MEDICAL VARIABLE FLOW INSUFFLATOR?

CABOT MEDICAL VARIABLE FLOW INSUFFLATOR is a medical device that received FDA 510(k) clearance on 1986-08-12. The listed applicant is Cabot Medical Corp.. The 510(k) number is K862310.

When did CABOT MEDICAL VARIABLE FLOW INSUFFLATOR receive FDA 510(k) clearance?

CABOT MEDICAL VARIABLE FLOW INSUFFLATOR received FDA 510(k) clearance on 1986-08-12, under 510(k) number K862310.

Who is the listed applicant for CABOT MEDICAL VARIABLE FLOW INSUFFLATOR?

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

What is the FDA product code for CABOT MEDICAL VARIABLE FLOW INSUFFLATOR?

The FDA product code for CABOT MEDICAL VARIABLE FLOW INSUFFLATOR is HES.

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 Cabot Medical Corp. 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.

K960148CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENTK946109CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPSK951972CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHSK951714CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBERK941743CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMPK9341153000 ELECTRONIC INSUFFLATOR MODIFICATION

View all 38 devices →

Related Devices (Code: HES)

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.

K000340HYSTALOG HSG CATHETERRocket Medical PlcK903209MAXI-FLOW INSUFFLATOR TUBING SET W/FILTERAdler Instrument Co.K903208MAXI-FLOW INSUFFLATOR TUBING SETAdler Instrument Co.K904473KRONNER MANIPUJECTORUnimar, Inc.K901413CORE DISPOSABLE INSUFFLATION TUBINGCore Dynamics, Inc.K891290SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETERCook Ob/Gyn

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.

↑