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FDA 510(k)

RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS

K-Number: K974066 · 1998-01-22

ApplicantMicroline Pentax, Inc.
Decision Date1998-01-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS 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 1998-01-22 under 510(k) number K974066. 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 FORCEPS LAPAROSCOPIC SURGICAL TIPS?

RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS is a medical device that received FDA 510(k) clearance on 1998-01-22. The listed applicant is Microline Pentax, Inc.. The 510(k) number is K974066.

When did RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS receive FDA 510(k) clearance?

RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS received FDA 510(k) clearance on 1998-01-22, under 510(k) number K974066.

Who is the listed applicant for RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS?

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 FORCEPS LAPAROSCOPIC SURGICAL TIPS?

The FDA product code for RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS 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 SCISSORSK970826SELECTA-TIP LAPAROSCOPIC SCISSORS

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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

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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