FDA 510(k)

LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION

K-Number: K925903 · 1992-12-30

Decision Date1992-12-30

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION 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 1992-12-30 under 510(k) number K925903. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION?

LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-12-30. The listed applicant is Birtcher Medical Systems, Inc.. The 510(k) number is K925903.

When did LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION receive FDA 510(k) clearance?

LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION received FDA 510(k) clearance on 1992-12-30, under 510(k) number K925903.

Who is the listed applicant for LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION?

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 LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION?

The FDA product code for LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION is GEI.

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Other records listing Birtcher Medical Systems, Inc. as applicant

K932779BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS.K944681LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES K930887BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600)K932987BIRTCHER LAPAROSCOPE AND ACCESSORIES K931771BIRTCHER ENDOSCOPIC CORKSCREW K931654BIRTCHER MAGNETIC RETRIEVER (GS-3100)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.