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FDA 510(k)

ETHICON ENDO-SURGERYOPTICAL DILATOR

K-Number: K093236 · 2009-11-10

ApplicantEthicon Endo-Surgery, Inc.
Decision Date2009-11-10
Product CodeKNQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ETHICON ENDO-SURGERYOPTICAL DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, Inc.. It received FDA 510(k) clearance on 2009-11-10 under 510(k) number K093236. 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 ETHICON ENDO-SURGERYOPTICAL DILATOR?

ETHICON ENDO-SURGERYOPTICAL DILATOR is a medical device that received FDA 510(k) clearance on 2009-11-10. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K093236.

When did ETHICON ENDO-SURGERYOPTICAL DILATOR receive FDA 510(k) clearance?

ETHICON ENDO-SURGERYOPTICAL DILATOR received FDA 510(k) clearance on 2009-11-10, under 510(k) number K093236.

Who is the listed applicant for ETHICON ENDO-SURGERYOPTICAL DILATOR?

The FDA 510(k) record lists Ethicon Endo-Surgery, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETHICON ENDO-SURGERYOPTICAL DILATOR?

The FDA product code for ETHICON ENDO-SURGERYOPTICAL DILATOR is KNQ.

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Other records listing Ethicon Endo-Surgery, 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.

K111195VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADSK110385ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTERK101520ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RHK102632ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLERK093896ETHICON ENDO SURGERY SLOTTED ANOSCOPEK091259ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS

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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 CorpK090183HERCULES 3 STAGE WIRE GUIDED DILATION BALLOONCook EndoscopyK082995SMART DILATORSafestitch MedicalK061937COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOONCook EndoscopyK061787MAXFORCE TTS SINGLE-USE BALLOON DILATORBoston Scientific CorpK060302INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDEDCordis Europa, N.V.

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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