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FDA 510(k)

MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL

K-Number: K854420 · 1985-11-22

ApplicantMeadox Surgimed, Inc.
Decision Date1985-11-22
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Surgimed, Inc.. It received FDA 510(k) clearance on 1985-11-22 under 510(k) number K854420. The device is classified under product code GDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL?

MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL is a medical device that received FDA 510(k) clearance on 1985-11-22. The listed applicant is Meadox Surgimed, Inc.. The 510(k) number is K854420.

When did MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL receive FDA 510(k) clearance?

MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL received FDA 510(k) clearance on 1985-11-22, under 510(k) number K854420.

Who is the listed applicant for MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL?

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

What is the FDA product code for MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL?

The FDA product code for MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL is GDM.

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Other records listing Meadox Surgimed, 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.

K944143MS CLASSIQUE BALLOON CATHETERK945061NOPROFILE OLBERT CATHETER SYSTEMK942382MS AMPLATZ EXTRA STIFF GUIDE WIREK930201ACECUT SUTOMATIC BIOPSY SYSTEMK911635MEADOX(R) SURGIMED(R) BIOPSY GUN IIK905181NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY

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Related Devices (Code: GDM)

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.

K071732MARROWMINERStemcor Systems, Inc.K971114BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K953082ILIAC CREST BONE MARROW ASPIRATION NEEDLEBaxter Healthcare CorpK953064BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K936207ENDO-NEEDLE INSTRUMENTGerard Medical, Inc.K930160ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLESymbiosis Corp.

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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