510(k) K061555

ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM by Anchor Products Co. — Product Code GCJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 31, 2006
Date Received: June 5, 2006
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Laparoscope, General & Plastic Surgery
Device Class: Class II
Regulation Number: 876.1500
Review Panel: SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Anchor Products Co.

K091930 — ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB (September 23, 2009)
K982073 — ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM (September 22, 1998)
K884862 — ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE (December 27, 1988)
K873124 — ANCHOR BIOPSY NEEDLE (September 8, 1987)
K831648 — ANCHOR BRAND SURGICAL NEEDLES (August 16, 1983)
K790405 — ANCHOR BRAND COUNT-TAINER (March 26, 1979)

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