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FDA 510(k)

RE-NEW LAPAROSCOPIC INSTRUMENTS

K-Number: K962119 · 1996-08-09

ApplicantMicroline Pentax, Inc.
Decision Date1996-08-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RE-NEW LAPAROSCOPIC INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Microline Pentax, Inc.. It received FDA 510(k) clearance on 1996-08-09 under 510(k) number K962119. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RE-NEW LAPAROSCOPIC INSTRUMENTS?

RE-NEW LAPAROSCOPIC INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1996-08-09. The listed applicant is Microline Pentax, Inc.. The 510(k) number is K962119.

When did RE-NEW LAPAROSCOPIC INSTRUMENTS receive FDA 510(k) clearance?

RE-NEW LAPAROSCOPIC INSTRUMENTS received FDA 510(k) clearance on 1996-08-09, under 510(k) number K962119.

Who is the listed applicant for RE-NEW LAPAROSCOPIC INSTRUMENTS?

The FDA 510(k) record lists Microline Pentax, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RE-NEW LAPAROSCOPIC INSTRUMENTS?

The FDA product code for RE-NEW LAPAROSCOPIC INSTRUMENTS is GEI.

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Other records listing Microline Pentax, 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.

K013695MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10K982984ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTSK981389DISPOSABLE RE-NEW FORCEPSK981188ELECTROSURGICAL CAUTERY PROBESK9807583 MM SELEC-TIP LAPAROSCOPIC SCISSORSK974066RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS

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Related Devices (Code: GEI)

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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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