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FDA 510(k)

BIRTCHER ENDOSCOPIC CORKSCREW

K-Number: K931771 · 1994-04-25

ApplicantBirtcher Medical Systems, Inc.
Decision Date1994-04-25
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BIRTCHER ENDOSCOPIC CORKSCREW 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 K931771. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIRTCHER ENDOSCOPIC CORKSCREW?

BIRTCHER ENDOSCOPIC CORKSCREW 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 K931771.

When did BIRTCHER ENDOSCOPIC CORKSCREW receive FDA 510(k) clearance?

BIRTCHER ENDOSCOPIC CORKSCREW received FDA 510(k) clearance on 1994-04-25, under 510(k) number K931771.

Who is the listed applicant for BIRTCHER ENDOSCOPIC CORKSCREW?

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 ENDOSCOPIC CORKSCREW?

The FDA product code for BIRTCHER ENDOSCOPIC CORKSCREW is HET.

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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)K936114BIRTCHER PERICARDIAL KNIVESK931654BIRTCHER MAGNETIC RETRIEVER (GS-3100)

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Related Devices (Code: HET)

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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