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FDA 510(k)

KERRISON RONGEURS

K-Number: K943583 · 1995-02-21

ApplicantEnterprise Medical Corp.
Decision Date1995-02-21
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KERRISON RONGEURS is the device name listed in this FDA 510(k) record. The listed applicant is Enterprise Medical Corp.. It received FDA 510(k) clearance on 1995-02-21 under 510(k) number K943583. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KERRISON RONGEURS?

KERRISON RONGEURS is a medical device that received FDA 510(k) clearance on 1995-02-21. The listed applicant is Enterprise Medical Corp.. The 510(k) number is K943583.

When did KERRISON RONGEURS receive FDA 510(k) clearance?

KERRISON RONGEURS received FDA 510(k) clearance on 1995-02-21, under 510(k) number K943583.

Who is the listed applicant for KERRISON RONGEURS?

The FDA 510(k) record lists Enterprise Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KERRISON RONGEURS?

The FDA product code for KERRISON RONGEURS is HAE.

Related Clinical Trials

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Other records listing Enterprise Medical Corp. 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.

K942431LAPOROSCOPIC SCISSORSK941816EMC FLEXIBLE BIOPSY FORCEPS

Related Devices (Code: HAE)

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.

K260446Tontarra Punches and RongeursTontarra Medizintechnik GmbHK242759Geister K-Rex rongeursGeister Medizin Technik GmbHK223596SQ.line KERRISONAesculap, Inc.K230256Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AGK221818Rebellion; Phantom Multi-Bite Kerrison RongeurMorpheus AGK210741KLS Martin Neuro RongeursKLS-Martin L.P.

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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