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FDA 510(k)

MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES

K-Number: K874952 · 1987-12-30

ApplicantSolway, Inc.
Decision Date1987-12-30
Product CodeHBG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES 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 K874952. The device is classified under product code HBG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES?

MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES 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 K874952.

When did MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES receive FDA 510(k) clearance?

MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES received FDA 510(k) clearance on 1987-12-30, under 510(k) number K874952.

Who is the listed applicant for MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES?

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 CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES?

The FDA product code for MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES is HBG.

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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: HBG)

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.

K252696LEGACYPhasor Health, LLCK153587Taps for Resorbable ScrewsSynthes (USA) Products, LLCK162884SpineGuard DSG Zavation Screw SystemSpineguard S.A.K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc.K122456MRII CRAINIAL DRILLMri Interventions, Inc.K022712HAND DRILL, MODEL 11-9901-7Medical Design, LLC

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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