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FDA 510(k)

BIRTCHER LAPAROSCOPE AND ACCESSORIES

K-Number: K932987 · 1994-04-25

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

Device Summary

BIRTCHER LAPAROSCOPE AND ACCESSORIES 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 K932987. 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 LAPAROSCOPE AND ACCESSORIES?

BIRTCHER LAPAROSCOPE AND ACCESSORIES 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 K932987.

When did BIRTCHER LAPAROSCOPE AND ACCESSORIES receive FDA 510(k) clearance?

BIRTCHER LAPAROSCOPE AND ACCESSORIES received FDA 510(k) clearance on 1994-04-25, under 510(k) number K932987.

Who is the listed applicant for BIRTCHER LAPAROSCOPE AND ACCESSORIES?

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 LAPAROSCOPE AND ACCESSORIES?

The FDA product code for BIRTCHER LAPAROSCOPE AND ACCESSORIES 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 ACCESSORIESK931771BIRTCHER ENDOSCOPIC CORKSCREWK930887BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600)K936114BIRTCHER PERICARDIAL KNIVESK931654BIRTCHER MAGNETIC RETRIEVER (GS-3100)

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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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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