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FDA 510(k)

BIRTCHER PERICARDIAL KNIVES

K-Number: K936114 · 1994-04-25

ApplicantBirtcher Medical Systems, Inc.
Decision Date1994-04-25
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIRTCHER PERICARDIAL KNIVES is the device name listed in this FDA 510(k) record. The listed applicant is Birtcher Medical Systems, Inc.. It received FDA 510(k) clearance on 1994-04-25 under 510(k) number K936114. 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 BIRTCHER PERICARDIAL KNIVES?

BIRTCHER PERICARDIAL KNIVES is a medical device that received FDA 510(k) clearance on 1994-04-25. The listed applicant is Birtcher Medical Systems, Inc.. The 510(k) number is K936114.

When did BIRTCHER PERICARDIAL KNIVES receive FDA 510(k) clearance?

BIRTCHER PERICARDIAL KNIVES received FDA 510(k) clearance on 1994-04-25, under 510(k) number K936114.

Who is the listed applicant for BIRTCHER PERICARDIAL KNIVES?

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

What is the FDA product code for BIRTCHER PERICARDIAL KNIVES?

The FDA product code for BIRTCHER PERICARDIAL KNIVES is GCJ.

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Other records listing Birtcher Medical Systems, 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.

K932779BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS.K944681LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIESK932987BIRTCHER LAPAROSCOPE AND ACCESSORIESK930887BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600)K931654BIRTCHER MAGNETIC RETRIEVER (GS-3100)K931771BIRTCHER ENDOSCOPIC CORKSCREW

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Related Devices (Code: GCJ)

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.

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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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