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FDA 510(k)

SURGITEK PERCUTANEOUS NEPHROSTOMY CATH

K-Number: K830226 · 1983-02-09

ApplicantMedical Engineering Corp.
Decision Date1983-02-09
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

SURGITEK PERCUTANEOUS NEPHROSTOMY CATH is the device name listed in this FDA 510(k) record. The listed applicant is Medical Engineering Corp.. It received FDA 510(k) clearance on 1983-02-09 under 510(k) number K830226. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITEK PERCUTANEOUS NEPHROSTOMY CATH?

SURGITEK PERCUTANEOUS NEPHROSTOMY CATH is a medical device that received FDA 510(k) clearance on 1983-02-09. The listed applicant is Medical Engineering Corp.. The 510(k) number is K830226.

When did SURGITEK PERCUTANEOUS NEPHROSTOMY CATH receive FDA 510(k) clearance?

SURGITEK PERCUTANEOUS NEPHROSTOMY CATH received FDA 510(k) clearance on 1983-02-09, under 510(k) number K830226.

Who is the listed applicant for SURGITEK PERCUTANEOUS NEPHROSTOMY CATH?

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

What is the FDA product code for SURGITEK PERCUTANEOUS NEPHROSTOMY CATH?

The FDA product code for SURGITEK PERCUTANEOUS NEPHROSTOMY CATH is LJE.

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Other records listing Medical Engineering 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.

K934141STAND ALONE CYSTOMETROGRAMK905289SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENTK903448SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDERK902773SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SETK884746SURGITEK FLAT T-SPANK883274SURGITEK (R) UROFLOW SYSTEM

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Related Devices (Code: LJE)

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.

K250448Disposable Percutaneous Nephrostomy Dilatation KitShenzhen Trious Medical Technology Co., Ltd.K222705Introducer NeedleYoucare Technology Co.,Ltd. (Wuhan)K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsColoplast Corp.K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp.K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-LocCook IncorporatedK190903Lawson Retrograde Nephrostomy Wire Puncture SetCook Incorporated

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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