Surgery – Instruments – Means for removing tonsils – adenoids or polyps
Reexamination Certificate
2008-03-24
2011-12-13
Hughes, S. Thomas (Department: 3731)
Surgery
Instruments
Means for removing tonsils, adenoids or polyps
Reexamination Certificate
active
08075567
ABSTRACT:
A surgical tissue retrieval instrument has a collapsible pouch at the distal end of an elongated pusher rod that is introduced into a patient's abdomen through a cannula. The instrument includes a two-jaw fork that forms a loop when in an unconstrained configuration and that supports the pouch. Deployment and operation of the fork and the pouch are controlled by a toggle means. The two jaws and the toggle means are slid in a hem surrounding the opening of the pouch when the device is assembled. An especially advantageous embodiment features two jaws of unequal length.
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Letter from Mark N. Melkerson, Director, Division of General, Restorative and Neurological Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Department of Health & Human Services dated Aug. 31, 2006.
Anchor Laparoscopic Tissue Retrieval System submitted to the U.S. Food and Drug Administration Center for Devices and Radiological Health Jun. 1, 2006.
Jul. 17, 2006 email from Della Hammond, Lead Reviewer, General Surgical Devices Branch, Division of General and Restorative Devices, Office of Device Evaluation, U.S. Food and Drug Administration Center for Devices and Radiological Health.
Indications for Use Concurrence of CDRH, Office of Device Evaluation (ODE) for Anchor Tissue Retrieval System, 510(k) No. K061555.
Tissue Retrieval Pouch Test Report for USP Intracutaneous Test prepared by Northview Pacific Laboratories Feb. 19, 1998, NV Report No. X8B006G.
Tissue Retrieval Pouch Test Report Lot ESP 9710-04,Cytotoxicity-Elution Test, prepared by Northview Pacific Laboratories Feb. 24, 1998, NV Report No. V8B007G.
Tissue Retrieval Pouch, Lot No. ESP9710-04, Maximization Sensitization Test Report prepared by Northview Pacific Laboratories Mar. 4, 1998, NV Report No. X8B007G.
Taylor James
Thrun Robert H.
Anchor Products Company
Cherskov & Flaynik
Hughes S. Thomas
Shi Katherine M
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