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FDA 510(k)

ABC LAPAROSCOPIC HANDPROBE

K-Number: K910889 · 1991-08-29

ApplicantBirtcher Medical Systems, Inc.
Decision Date1991-08-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ABC LAPAROSCOPIC HANDPROBE 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 1991-08-29 under 510(k) number K910889. 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 ABC LAPAROSCOPIC HANDPROBE?

ABC LAPAROSCOPIC HANDPROBE is a medical device that received FDA 510(k) clearance on 1991-08-29. The listed applicant is Birtcher Medical Systems, Inc.. The 510(k) number is K910889.

When did ABC LAPAROSCOPIC HANDPROBE receive FDA 510(k) clearance?

ABC LAPAROSCOPIC HANDPROBE received FDA 510(k) clearance on 1991-08-29, under 510(k) number K910889.

Who is the listed applicant for ABC LAPAROSCOPIC HANDPROBE?

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 ABC LAPAROSCOPIC HANDPROBE?

The FDA product code for ABC LAPAROSCOPIC HANDPROBE is GEI.

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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 ACCESSORIESK930887BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600)K932987BIRTCHER LAPAROSCOPE AND ACCESSORIESK931771BIRTCHER ENDOSCOPIC CORKSCREWK931654BIRTCHER MAGNETIC RETRIEVER (GS-3100)

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Related Devices (Code: GEI)

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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