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FDA 510(k)

MANUAL RONGEUR

K-Number: K874954 · 1987-12-30

ApplicantSolway, Inc.
Decision Date1987-12-30
Product CodeHTX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MANUAL RONGEUR is the device name listed in this FDA 510(k) record. The listed applicant is Solway, Inc.. It received FDA 510(k) clearance on 1987-12-30 under 510(k) number K874954. The device is classified under product code HTX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANUAL RONGEUR?

MANUAL RONGEUR is a medical device that received FDA 510(k) clearance on 1987-12-30. The listed applicant is Solway, Inc.. The 510(k) number is K874954.

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

MANUAL RONGEUR received FDA 510(k) clearance on 1987-12-30, under 510(k) number K874954.

Who is the listed applicant for MANUAL RONGEUR?

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 MANUAL RONGEUR?

The FDA product code for MANUAL RONGEUR is HTX.

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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 INSTRUMENTSK875043RONGEUR (NEUROSURGICAL INSTRUMENTS)K874966TUNING FORKS

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Related Devices (Code: HTX)

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.

K841621BACK RADIUS CUTTERPlastafil, Inc.K841620FRONT RADIUS CUTTERPlastafil, Inc.K780397ORTHOPEDIC FORCEPSOrthopedic Equipment Co., Inc.K760325SURGICAL INSTRUMENTS, ORTHOPEDICDepuy, Inc.

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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