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FDA 510(k)

ENDOPATH OPTICAL ACCESS NEEDKLE

K-Number: K951444 · 1995-04-25

ApplicantEthicon Endo-Surgery, Inc.
Decision Date1995-04-25
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOPATH OPTICAL ACCESS NEEDKLE 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 1995-04-25 under 510(k) number K951444. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOPATH OPTICAL ACCESS NEEDKLE?

ENDOPATH OPTICAL ACCESS NEEDKLE is a medical device that received FDA 510(k) clearance on 1995-04-25. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K951444.

When did ENDOPATH OPTICAL ACCESS NEEDKLE receive FDA 510(k) clearance?

ENDOPATH OPTICAL ACCESS NEEDKLE received FDA 510(k) clearance on 1995-04-25, under 510(k) number K951444.

Who is the listed applicant for ENDOPATH OPTICAL ACCESS NEEDKLE?

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 ENDOPATH OPTICAL ACCESS NEEDKLE?

The FDA product code for ENDOPATH OPTICAL ACCESS NEEDKLE is GCJ.

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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: GCJ)

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.

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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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