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FDA 510(k)

RONGEUR (NEUROSURGICAL INSTRUMENTS)

K-Number: K875043 · 1988-01-22

ApplicantSolway, Inc.
Decision Date1988-01-22
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RONGEUR (NEUROSURGICAL INSTRUMENTS) is the device name listed in this FDA 510(k) record. The listed applicant is Solway, Inc.. It received FDA 510(k) clearance on 1988-01-22 under 510(k) number K875043. 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 RONGEUR (NEUROSURGICAL INSTRUMENTS)?

RONGEUR (NEUROSURGICAL INSTRUMENTS) is a medical device that received FDA 510(k) clearance on 1988-01-22. The listed applicant is Solway, Inc.. The 510(k) number is K875043.

When did RONGEUR (NEUROSURGICAL INSTRUMENTS) receive FDA 510(k) clearance?

RONGEUR (NEUROSURGICAL INSTRUMENTS) received FDA 510(k) clearance on 1988-01-22, under 510(k) number K875043.

Who is the listed applicant for RONGEUR (NEUROSURGICAL INSTRUMENTS)?

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

What is the FDA product code for RONGEUR (NEUROSURGICAL INSTRUMENTS)?

The FDA product code for RONGEUR (NEUROSURGICAL INSTRUMENTS) is HAE.

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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 Solway, 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.

K874960CARDIOVASCULAR SURGICAL INSTRUMENTSK874962FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULASK874956SELF-RETAINING RETRACTOR FOR NEUROSURGERYK874964DENTAL HAND INSTRUMENTSK874966TUNING FORKSK874950MICROSURGICAL INSTRUMENTS

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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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