510(k) K924058

TROCAR by Endo Technic Corp. — Product Code GCJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 30, 1993
Date Received: August 12, 1992
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 Endo Technic Corp.

K990908 — MILLENNIUM (May 27, 1999)
K971459 — DERMALASE (July 18, 1997)
K925079 — LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) (August 24, 1994)
K930756 — LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE (March 9, 1994)
K925114 — LAPAROSCOPIC INSTRUMENTS (February 28, 1994)
K914825 — 1-125 ENDOSEED (March 19, 1992)
K910200 — LASER-35 (May 9, 1991)
K864976 — SOLUSET CALCIUM DEMINERALIZING SOLUTION (February 27, 1987)
K862129 — SET CANAL SEALER PASTE (July 22, 1986)

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