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FDA 510(k)

PIVOTAL SCISSOR

K-Number: K972510 · 1997-11-13

ApplicantUrohealth Systems, Inc.
Decision Date1997-11-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PIVOTAL SCISSOR is the device name listed in this FDA 510(k) record. The listed applicant is Urohealth Systems, Inc.. It received FDA 510(k) clearance on 1997-11-13 under 510(k) number K972510. 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 PIVOTAL SCISSOR?

PIVOTAL SCISSOR is a medical device that received FDA 510(k) clearance on 1997-11-13. The listed applicant is Urohealth Systems, Inc.. The 510(k) number is K972510.

When did PIVOTAL SCISSOR receive FDA 510(k) clearance?

PIVOTAL SCISSOR received FDA 510(k) clearance on 1997-11-13, under 510(k) number K972510.

Who is the listed applicant for PIVOTAL SCISSOR?

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

What is the FDA product code for PIVOTAL SCISSOR?

The FDA product code for PIVOTAL SCISSOR is GEI.

Related Clinical Trials

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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Other records listing Urohealth Systems, 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.

K980617MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTERK970107INTUBATION ENDOSCOPE AND INTRODUCER SHEATH

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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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