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FDA 510(k)

SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM

K-Number: K905459 · 1991-04-05

ApplicantAngiosystems, Inc.
Decision Date1991-04-05
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM is the device name listed in this FDA 510(k) record. The listed applicant is Angiosystems, Inc.. It received FDA 510(k) clearance on 1991-04-05 under 510(k) number K905459. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM?

SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM is a medical device that received FDA 510(k) clearance on 1991-04-05. The listed applicant is Angiosystems, Inc.. The 510(k) number is K905459.

When did SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM receive FDA 510(k) clearance?

SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM received FDA 510(k) clearance on 1991-04-05, under 510(k) number K905459.

Who is the listed applicant for SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM?

The FDA 510(k) record lists Angiosystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM?

The FDA product code for SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM is LRO.

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Other records listing Angiosystems, 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.

K905464MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLINGK905461PROCEDURE KIT/ROUTINE DENTAL PROCEDURESK905466STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPEK905465STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPEK905460STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERYK905462PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES

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Related Devices (Code: LRO)

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.

K213481Medline General Surgery TrayMedline Industries, Inc.K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical ProductsK023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, LLC

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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