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FDA 510(k)

PORGES STEPPED NEOPLEX DILATOR

K-Number: K883526 · 1988-10-28

ApplicantPorges Corp.
Decision Date1988-10-28
Product CodeKNQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PORGES STEPPED NEOPLEX DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Porges Corp.. It received FDA 510(k) clearance on 1988-10-28 under 510(k) number K883526. The device is classified under product code KNQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORGES STEPPED NEOPLEX DILATOR?

PORGES STEPPED NEOPLEX DILATOR is a medical device that received FDA 510(k) clearance on 1988-10-28. The listed applicant is Porges Corp.. The 510(k) number is K883526.

When did PORGES STEPPED NEOPLEX DILATOR receive FDA 510(k) clearance?

PORGES STEPPED NEOPLEX DILATOR received FDA 510(k) clearance on 1988-10-28, under 510(k) number K883526.

Who is the listed applicant for PORGES STEPPED NEOPLEX DILATOR?

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

What is the FDA product code for PORGES STEPPED NEOPLEX DILATOR?

The FDA product code for PORGES STEPPED NEOPLEX DILATOR is KNQ.

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Other records listing Porges 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.

K900269PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGEK900031MODIFIED PEDIATRIC SILICONE FOLEY CATHETERSK896505PORGES UNIVERSAL HANDLESK896503PORGES ERCP CATHETERSK896425PORGES CYTOLOGY BRUSHESK896507PORGES DIATHERMY SNARE

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Related Devices (Code: KNQ)

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.

K122924CRE FIXED WIRE BALLON DILATION CATHETERBoston Scientific CorpK093236ETHICON ENDO-SURGERYOPTICAL DILATOREthicon Endo-Surgery, Inc.K090183HERCULES 3 STAGE WIRE GUIDED DILATION BALLOONCook EndoscopyK082995SMART DILATORSafestitch MedicalK061937COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOONCook EndoscopyK061787MAXFORCE TTS SINGLE-USE BALLOON DILATORBoston Scientific 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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