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FDA 510(k)

AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH

K-Number: K922123 · 1993-02-01

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1993-02-01
Product CodeGCI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1993-02-01 under 510(k) number K922123. 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 AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH?

AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH is a medical device that received FDA 510(k) clearance on 1993-02-01. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K922123.

When did AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH receive FDA 510(k) clearance?

AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH received FDA 510(k) clearance on 1993-02-01, under 510(k) number K922123.

Who is the listed applicant for AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH?

The FDA product code for AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH is GCI.

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Other records listing United States Surgical, A Division of Tyco Healthc as applicant

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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.K930302BIRTCHER SURE CLEAN INSTRUMENT SYSTEMBirtcher Medical Systems, Inc.K930496GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPSBirtcher Medical Systems, 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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