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FDA 510(k)

(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET

K-Number: K863120 · 1986-10-24

ApplicantCook Urological, Inc.
Decision Date1986-10-24
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1986-10-24 under 510(k) number K863120. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the (STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET?

(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET is a medical device that received FDA 510(k) clearance on 1986-10-24. The listed applicant is Cook Urological, Inc.. The 510(k) number is K863120.

When did (STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET receive FDA 510(k) clearance?

(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET received FDA 510(k) clearance on 1986-10-24, under 510(k) number K863120.

Who is the listed applicant for (STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET?

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

What is the FDA product code for (STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET?

The FDA product code for (STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET is KOB.

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Other records listing Cook Urological, 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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)K0917673 WAY SILICONE FOLEY BALLOON CATHETERK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400K082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERK082536COOK WIRE GUIDESK082319INJEKT FILIFORM INJECTION NEEDLE

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Related Devices (Code: KOB)

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.

K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc.K181097Cook Cystostomy Catheter SetCook IncorporatedK182709One-Step Suprapubic IntroducerCook IncorporatedK182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook IncorporatedK120127SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEMSwan Valley Medical, IncorporatedK014002ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890Fortune Medical Instrument Corp.

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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