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FDA 510(k)

SELECTA-TIP LAPAROSCOPIC SCISSORS

K-Number: K970826 · 1997-03-28

ApplicantMicroline Pentax, Inc.
Decision Date1997-03-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SELECTA-TIP LAPAROSCOPIC SCISSORS 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 1997-03-28 under 510(k) number K970826. 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 SELECTA-TIP LAPAROSCOPIC SCISSORS?

SELECTA-TIP LAPAROSCOPIC SCISSORS is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is Microline Pentax, Inc.. The 510(k) number is K970826.

When did SELECTA-TIP LAPAROSCOPIC SCISSORS receive FDA 510(k) clearance?

SELECTA-TIP LAPAROSCOPIC SCISSORS received FDA 510(k) clearance on 1997-03-28, under 510(k) number K970826.

Who is the listed applicant for SELECTA-TIP LAPAROSCOPIC SCISSORS?

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 SELECTA-TIP LAPAROSCOPIC SCISSORS?

The FDA product code for SELECTA-TIP LAPAROSCOPIC SCISSORS 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.

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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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