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FDA 510(k)

SURGITEK PERCUTANEOUS NEPHROST. STENT

K-Number: K821776 · 1982-08-10

ApplicantMedical Engineering Corp.
Decision Date1982-08-10
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

SURGITEK PERCUTANEOUS NEPHROST. STENT 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 1982-08-10 under 510(k) number K821776. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITEK PERCUTANEOUS NEPHROST. STENT?

SURGITEK PERCUTANEOUS NEPHROST. STENT is a medical device that received FDA 510(k) clearance on 1982-08-10. The listed applicant is Medical Engineering Corp.. The 510(k) number is K821776.

When did SURGITEK PERCUTANEOUS NEPHROST. STENT receive FDA 510(k) clearance?

SURGITEK PERCUTANEOUS NEPHROST. STENT received FDA 510(k) clearance on 1982-08-10, under 510(k) number K821776.

Who is the listed applicant for SURGITEK PERCUTANEOUS NEPHROST. STENT?

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 NEPHROST. STENT?

The FDA product code for SURGITEK PERCUTANEOUS NEPHROST. STENT 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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