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FDA 510(k)

SELF-RETAINING RETRACTOR FOR NEUROSURGERY

K-Number: K874956 · 1988-01-28

ApplicantSolway, Inc.
Decision Date1988-01-28
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SELF-RETAINING RETRACTOR FOR NEUROSURGERY is the device name listed in this FDA 510(k) record. The listed applicant is Solway, Inc.. It received FDA 510(k) clearance on 1988-01-28 under 510(k) number K874956. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELF-RETAINING RETRACTOR FOR NEUROSURGERY?

SELF-RETAINING RETRACTOR FOR NEUROSURGERY is a medical device that received FDA 510(k) clearance on 1988-01-28. The listed applicant is Solway, Inc.. The 510(k) number is K874956.

When did SELF-RETAINING RETRACTOR FOR NEUROSURGERY receive FDA 510(k) clearance?

SELF-RETAINING RETRACTOR FOR NEUROSURGERY received FDA 510(k) clearance on 1988-01-28, under 510(k) number K874956.

Who is the listed applicant for SELF-RETAINING RETRACTOR FOR NEUROSURGERY?

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 SELF-RETAINING RETRACTOR FOR NEUROSURGERY?

The FDA product code for SELF-RETAINING RETRACTOR FOR NEUROSURGERY is GZT.

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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 SPATULASK874964DENTAL HAND INSTRUMENTSK875043RONGEUR (NEUROSURGICAL INSTRUMENTS)K874966TUNING FORKSK874950MICROSURGICAL INSTRUMENTS

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Related Devices (Code: GZT)

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.

K252995Durashield Device KitSurGenTec, LLCK210615Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)Thompson Surgical Instruments, Inc.K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)Vycor Medical, Inc.K202072MindsEye Expandable PortMinnetronix Neuro, Inc.K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbHK172433NICO BrainPathNico Corporation

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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