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FDA 510(k)

SPECIAL RONGEUR

K-Number: K903401 · 1990-08-10

ApplicantSur-Med Instruments, Inc.
Decision Date1990-08-10
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPECIAL RONGEUR is the device name listed in this FDA 510(k) record. The listed applicant is Sur-Med Instruments, Inc.. It received FDA 510(k) clearance on 1990-08-10 under 510(k) number K903401. 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 SPECIAL RONGEUR?

SPECIAL RONGEUR is a medical device that received FDA 510(k) clearance on 1990-08-10. The listed applicant is Sur-Med Instruments, Inc.. The 510(k) number is K903401.

When did SPECIAL RONGEUR receive FDA 510(k) clearance?

SPECIAL RONGEUR received FDA 510(k) clearance on 1990-08-10, under 510(k) number K903401.

Who is the listed applicant for SPECIAL RONGEUR?

The FDA 510(k) record lists Sur-Med Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECIAL RONGEUR?

The FDA product code for SPECIAL RONGEUR is HAE.

Related Clinical Trials

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Other records listing Sur-Med Instruments, 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.

K870897KODNER ANAL PERIONEAL RETRACTORK870978T-TUBE INSERTER

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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