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FDA 510(k)

MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY

K-Number: K983538 · 1998-11-06

ApplicantSolos Endoscopy, Inc.
Decision Date1998-11-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY is the device name listed in this FDA 510(k) record. The listed applicant is Solos Endoscopy, Inc.. It received FDA 510(k) clearance on 1998-11-06 under 510(k) number K983538. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY?

MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY is a medical device that received FDA 510(k) clearance on 1998-11-06. The listed applicant is Solos Endoscopy, Inc.. The 510(k) number is K983538.

When did MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY receive FDA 510(k) clearance?

MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY received FDA 510(k) clearance on 1998-11-06, under 510(k) number K983538.

Who is the listed applicant for MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY?

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

What is the FDA product code for MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY?

The FDA product code for MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY is GCJ.

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Related Devices (Code: GCJ)

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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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