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FDA 510(k)

BIRTCHER SURE CLEAN INSTRUMENT SYSTEM

K-Number: K930302 · 1993-10-27

ApplicantBirtcher Medical Systems, Inc.
Decision Date1993-10-27
Product CodeGCI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIRTCHER SURE CLEAN INSTRUMENT SYSTEM 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 1993-10-27 under 510(k) number K930302. The device is classified under product code GCI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIRTCHER SURE CLEAN INSTRUMENT SYSTEM?

BIRTCHER SURE CLEAN INSTRUMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1993-10-27. The listed applicant is Birtcher Medical Systems, Inc.. The 510(k) number is K930302.

When did BIRTCHER SURE CLEAN INSTRUMENT SYSTEM receive FDA 510(k) clearance?

BIRTCHER SURE CLEAN INSTRUMENT SYSTEM received FDA 510(k) clearance on 1993-10-27, under 510(k) number K930302.

Who is the listed applicant for BIRTCHER SURE CLEAN INSTRUMENT SYSTEM?

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 SURE CLEAN INSTRUMENT SYSTEM?

The FDA product code for BIRTCHER SURE CLEAN INSTRUMENT SYSTEM is GCI.

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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)

View all 13 devices →

Related Devices (Code: GCI)

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.

K021747DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTORSurgicon, Inc.K003222MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTERComputer Motion, Inc.K001362KARL STORZ 3D VIDEO SYSTEMKarl Storz Imaging, Inc.K933515BOOTY ENDOSCOPE WARMERT-Med, Inc.K930496GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPSBirtcher Medical Systems, Inc.K922123AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCHUnited States Surgical, A Division of Tyco Healthc

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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