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FDA 510(k)

CATHETER BUBBLE STAND

K-Number: K813487 · 1981-12-31

ApplicantAccurate Surgical Instruments Co.
Decision Date1981-12-31
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATHETER BUBBLE STAND is the device name listed in this FDA 510(k) record. The listed applicant is Accurate Surgical Instruments Co.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813487. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER BUBBLE STAND?

CATHETER BUBBLE STAND is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Accurate Surgical Instruments Co.. The 510(k) number is K813487.

When did CATHETER BUBBLE STAND receive FDA 510(k) clearance?

CATHETER BUBBLE STAND received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813487.

Who is the listed applicant for CATHETER BUBBLE STAND?

The FDA 510(k) record lists Accurate Surgical Instruments Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATHETER BUBBLE STAND?

The FDA product code for CATHETER BUBBLE STAND is FKX.

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Other records listing Accurate Surgical Instruments Co. 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.

K950042SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETERK920515INSERTIONK910786TROCAR (FALLER STYLET)K910785TITANIUM CATHETER EXTENDERK910787TITANIUM CONNECTOR (2 PART)K862046SWAN-NECK PERITONEAL DIALYSIS CATHETERS

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Related Devices (Code: FKX)

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.

K250523Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)Simergent, LLCK243371Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1Byonyks Pvt, Ltd.K220935Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone AppIren-Medical, Ltd.K222318Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLCK212522Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLCK212658CloudCath Peritoneal Dialysis Drain Set Monitoring SystemCloudcath

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.

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